MINISTRY OF
HEALTH OF VIETNAM |
SOCIALIST
REPUBLIC OF VIETNAM |
No. 05/2022/TT-BYT |
Hanoi, August 01, 2022 |
ELABORATING DECREE NO. 98/2021/ND-CP DATED NOVEMBER 8, 2021 OF THE GOVERNMENT ON MANAGEMENT OF MEDICAL DEVICES
Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of Government on functions, tasks, powers, and organizational structure of Ministry of Health;
Pursuant to Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices;
At the request of Director of Department of Medical Equipment and Construction;
Minister of Health promulgates Circular elaborating Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on management of medical devices.
1. This Circular elaborates Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on management of medical devices (hereinafter referred to as “Decree No. 98/2021/ND-CP”).
a) Classification of medical devices under Clause 5 Article 5 of Decree No. 98/2021/ND-CP ;
b) Addition to the list of in vitro diagnostic medical devices that are not required to undergo quality inspection by Vietnam’s competent authorities under Point dd Clause 3 Article 30 of Decree No. 98/2021/ND-CP ;
c) List of class B, class C, and class D medical devices purchased and sold as common commodities mentioned under Clause 1 Article 42 of Decree No. 98/2021/ND-CP ;
d) List of medical devices to be inspected for safety and technical functions under Clause 10 Article 70 of Decree No. 98/2021/ND-CP ;
dd) List of medical devices to be granted import permit under Point d Clause 2 Article 76 of Decree No. 98/2021/ND-CP.
2. Annuls documents on management of medical devices.
Article 2. Regulations on classification of medical devices
1. A medical device or multiple medical devices shall be classified in order to determine level of risks and be granted registration number.
2. The classification of a medical device or multiple medical devices must rely on the rules for classification using A, B, C, D levels of risks (details are prescribed under Appendix I attached hereto).
3. Sample of medical device classification results shall conform to Appendix II hereof.
1. Granted Certificate of Free Sale by any of the following countries, organizations:
a) Food and Drug Administration (FDA) - United States of America;
b) Therapeutic Goods Administration (TGA) - Australia;
c) Health Canada;
d) Ministry of Health, Labour and Welfare (MHLW) - Japan;
dd) Pharmaceuticals and Medical Devices Agency (PMDA) - Japan;
e) National Medical Products Administration (NMPA) - China;
g) Ministry of Food & Drug Safety (MFDS) - Korea;
h) EU member states as per Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.
2. Granted registration number or certificate of registration, import permit for commercial purposes in Vietnam, except for cases where such items have been revoked.
3. Other than in vitro reagents, calibrators, control materials.
1. Personal blood pressure monitors.
2. Fingertip pulse oximeter (SpO2).
3. Baby nasal aspirators.
4. Electronic thermometers, infrared thermometers.
5. Medical devices used to measure blood glucose: blood glucose monitoring device, lancing device, test strip, lancet, control solution, calibrators.
6. Nebulizers.
7. Medical tape, gauze pads.
8. Artificial tears classified as medical devices.
9. Condoms.
10. Vaginal contraceptive film (contains no drugs).
11. Vaginal lubricants classified as medical devices.
12. Electrical heating and cooling packs.
13. Class B in vitro diagnostic (ivd) medical device for self-testing.
14. In vitro diagnostic (ivd) medical device for self-testing of HIV, SARS-CoV-2.
1. Ventilators.
2. Anaesthetic machines.
3. Electric scalpels.
4. Infant incubators.
5. Defibrillators.
6. Hemodialysis machines.
1. X-ray imaging devices.
2. Magnetic resonance systems.
3. Diagnostic ultrasound equipment.
4. Diagnostic endoscopy system.
5. Cyclotron system.
6. Diagnostic devices using radioactive isotopes (PET, PET/CT, SPECT, SPECT/CT, iodine concentration measuring instrument for I130, I131).
7. Autorefractors, ophthalmometers.
8. Electrophysiology equipment (EEG, ECG, EMG machines).
9. Electroretinography machines.
10. Bone densitometer.
11. Optical coherence tomography (OCT) machine; Non-mydriatic retinal camera.
12. Doppler fetal monitors.
13. Spirometers.
14. Biochemistry analyzers; Blood gas and electrolyte analyzers.
15. Hematology analyzers; Blood type analysis instruments.
16. Coagulation analyzers; Erythrocyte sedimentation rate analyzers.
17. ELISA test system.
18. Cellular extraction system.
19. Platelet aggregation and platelet function analyzers.
20. Microbial identification instruments.
21. Immunoassay analyzers.
22. In vitro reagents, calibrators, and controlled materials.
23. Treatment devices using X-ray.
24. Endoscopic surgical system.
25. Radiotherapy equipment (Cobalt machine, Linear accelerator for cancer treatment, Gamma Knife, Brachytherapy equipment of all kinds).
26. Patient monitors.
27. Infusion pump; Electric syringe pump.
28. Scalpel (high voltage current, laser, ultrasound).
29. Surgical microscopes.
30. Prostatectomy surgery set.
31. Heart–lung machines.
32. Surgical navigation equipment.
33. Cryosurgery devices.
34. Infant incubators; Heaters for infants.
35. Anaesthetic machines.
36. Ventilators.
37. Implantable cardioverter-defibrillators.
38. Hyperbaric oxygen therapy chambers.
39. Extracorporeal/intracorporeal shock wave lithotripsy.
40. High Intensity Focused Ultrasound (HIFU) system.
41. Hemofiltration devices.
42. Ophthalmology surgical system (Laser Excimer, Phemtosecond Laser, Phaco, Vitreous cutter, Microkeratomes).
43. Glasses, contact lenses (myopia, hyperopia, mixed astigmatism) and contact lens solutions.
44. Laser devices for treatment in ophthalmology.
45. Long-term implantable devices and instrument (more than 30 days).
46. Invasive devices and instruments in cardiology and cranial nerve.
1. This Circular comes into force from August 01, 2022.
2. Provisions elaborating Decree No. 98/2021/ND-CP under this Circular comes into force from the effective date of Decree No. 98/2021/ND-CP.
3. Form No. 13.01, Form No. 13.02 under Appendix I and Form under Appendix V of Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health expire from the effective date hereof.
4. The following documents expire from January 1, 2022:
a) Circular No. 39/2016/TT-BYT dated October 28, 2016 of the Minister of Health;
b) Circular No. 46/2017/TT-BYT dated December 15, 2017 of the Minister of Health;
c) Circular No. 33/2020/TT-BYT dated December 31, 2020 of the Minister of Health;
d) Clause 1 Article 1 of Circular No. 23/2021/TT-BYT dated December 9, 2021 of the Minister of Health.
Article 8. Roadmap for implementation
1. For medical devices specified under Clauses 1, 2, and 3 Article 5 of this Circular:
a) In case these medical devices are procured after December 31, 2022, they must undergo safety and technical inspection as prescribed by Minister of Health;
b) In case these medical devices are procured before January 1, 2023, they must be adequately inspected before June 1, 2023 in accordance with the procedures promulgated by the Minister of Health.
2. For medical devices specified under Clauses 4, 5, and 6 Article 5 of this Circular:
a) In case these medical devices are procured after December 31, 2023, they must undergo safety and technical inspection as prescribed by Minister of Health;
b) In case these medical devices are procured before January 1, 2024, they must be adequately inspected before June 1, 2024 in accordance with the procedures promulgated by the Minister of Health.
Article 9. Organizing implementation
Chief of the Ministry Office, Chief Ministry Inspectorates, Directors, General Directors affiliated to the Ministry of Health, Directors of Departments of Health of provinces and central-affiliated cities and other relevant organizations and individuals are responsible for the implementation of this Circular.
Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health for consideration./.
|
PP. MINISTER |
APPENDIX I
CLASSIFICATION OF MEDICAL DEVICES
(Promulgated together with Circular No. 05/2022/TT-BYT dated August 01, 2022 of
the Minister of Health)
Section 1
RULES FOR CLASSIFICATION OF MEDICAL DEVICES
Part I
DEFINITIONS
For the purposes of this document, the terms below are construed as follows:
1. Active medical device means any medical device, operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements to between an active medical device and the patients, without any significant change, are not considered to be active medical devices.
2. Active therapeutic device means any medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap.
3. Active device intended for diagnosis means any medical device, whether used alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or to support in treating physiological conditions, states of health, illnesses or congenital deformities.
4. Body orifice means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma or permanent tracheotomy.
5. Central circulatory system means the major intern blood vessels including the following:
a) Pulmonary artery (Arteriae pulmonales)
b) Ascending aorta (Aorta ascendens)
c) Coronary artery (Arteriae coro nariae)
d) Common carotid artery (Arteria carotis communis)
dd) External carotid artery (Arteria carotis externa)
e) Internal carotid artery (Arteria carotis interna)
g) Cerebella arteries (Arteriae cerebrates)
h) Brachiocephalic trunk (Truncus brachiocephalicus)
i) Thoracic aorta (Thoracica aorta)
k) Abdominal aorta (Abdominalis aorta)
l) Common iliac arteries (Arteriae ilica communis)
m) Descending aorta to the bifurcation of aorta (Aorta descendens to the bifurcatio aortae)
n) Aortic arch (Arcus aorta)
o) Cardiac veins (Venae cordis)
p) Pulmonary vein (Venae pulmonales)
q) Superior vena cava (Venae cava superior)
r) Inferior vena cava (Venae cava inferior)
6. Central nervous system refers to the brain, meninges and spinal cord.
7. Continuous use of a medical device means the uninterrupted use of the medical device, not including any temporary interruption of its use during a procedure or any temporary removal or the medical device for purposes such as cleaning or disinfection; or the accumulated use of the medical device by replacing it immediately with another medical device of the same type, as intended by its product owner.
8. Transient use means continuous use for less than 60 minutes.
9. Short-term use means continuous use for between 60 minutes and 30 days.
10. Long-term use means continuous use for more than 30 days.
11. Immediate danger means a situation where the patient is at risk of either losing life or an important physiological function if no preventative measure is taken.
12. Invasive medical device means a medical device which, in whole or in part, penetrates inside the body either through a body orifice or through the surface of the body, including: implantable medical devices, surgically invasive medical devices, medical devices through body orifices and medical devices through body surface.
13. Implantable medical device means any medical device which is, through surgical intervention, intended to be totally introduced into the human body or to replace an epithelial surface or the surface of the eye, including those intended for partial introduction into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days.
14. Surgically invasive medical device means an invasive medical device that penetrates inside the body through the surface of the body with the aid of surgical operation, including medical devices that penetrate inside the body other than through a natural body orifice.
15. In vitro diagnostic (IVD) medical device for self-testing means any IVD medical device intended by the product owner for use by lay persons.
16. Near-patient testing means any testing performed outside a laboratory environment or at the side of the patient.
17. Reagent means any chemical, biological or immunological components solutions or preparations intended by the product owner to be used as IVD medical devices.
18. Specimen receptacle means an IVD medical device, whether vacuum-type or not, specifically intended by their product owner for the primary containment of specimens derived from the human body.
19. Transmissible agent means an agent capable of being transmitted to a person, as a communicable, infectious or contagious disease.
20. Transmission means the conveyance of a disease to a person.
21. Life supporting or life sustaining device means a medical device that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life.
Part II
RULES FOR CLASSIFICATION OF MEDICAL DEVICES OTHER THAN IVD MEDICAL DEVICES
A. NON-INVASIVE OF MEDICAL DEVICES
Rule 1. All non-invasive medical devices which come into contact with injured skin:
1. are in Class A if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates only i.e. healing they heal by primary intent.
2. are in Class B if they are intended to be used principally with wounds which have breached the dermis, including medical devices principally intended to manage the microenvironment of a wound.
3. Unless they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent, in which case they are in Class C.
Rule 2. Non-invasive medical devices intended for channeling or storing
All non-invasive medical devices intended for channeling or storing body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class A, unless:
1. they may be connected to an active medical device in Class B or a higher class, in which case they are Class B.
2. they are intended for channeling blood, storing or channeling other body liquids, or storing organs, parts of organs or body tissues, in which case they are Class B.
3. they are blood bags, in which case they are Class C.
Rule 3. Non-invasive of medical devices intended for modifying the biological or chemical composition
All non-invasive medical devices intended for modifying the biological or chemical composition of blood, other bodily liquids or other liquids intended for infusion into the body are in Class C, unless the treatment consists of filtration, centrifuging or exchanges of gas or heat, in which case they are in Class B.
Rule 4. Other non-invasive of medical devices
All other non-invasive medical devices are in Class A.
B. INVASIVE OF MEDICAL DEVICES
Rule 5. Invasive of medical devices with respect to body orifices other than those surgically invasive
1. All invasive medical devices with respect to body orifices (other than those which are surgically invasive) and which are not intended for connection to an active medical device, or are intended for connection to a Class A medical device only are in Class A if they are intended for transient use. Unless they are intended by its product owner for use on the external surface of any eyeball; or it is liable to be absorbed by the mucous membrane, in which case they are in Class B.
2. All invasive medical devices with respect to body orifices (other than those which are surgically invasive) and which are not intended for connection to an active medical device, or are intended for connection to a Class A medical device only are in Class B if they are intended for short-term use. Unless they are intended for use in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, in which case they are in Class A.
3. All invasive medical devices with respect to body orifices (other than those which are surgically invasive) and which are not intended for connection to an active medical device, or are intended for connection to a Class A medical device only are in Class C if they are intended for long-term use. Unless they are intended for use in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane, in which case they are in Class B.
4. All invasive medical devices with respect to body orifices (other than those which are surgically invasive) that are intended to be connected to an active medical device in Class B or a higher class are in Class B.
Rule 6. Surgically invasive medical devices intended for transient use
All surgically invasive medical devices intended for transient use are in Class B, unless:
1. they are reusable surgical instruments, in which case they are in Class A.
2. they are intended to supply energy in the form of ionizing radiation, in which case they are in Class C.
3. they are intended to have a biological effect or be wholly or mainly absorbed, in which case they are in Class C.
4. they are intended to administer medicinal products by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which they are in Class C.
5. they are they are intended specifically for use in direct contact with the central nervous system, in which case they are in Class D.
6. they are intended specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class D.
Rule 7. Surgically invasive medical devices intended for short-term use
All surgically invasive medical devices intended for short-term use are in Class B, unless:
1. they are intended to administer medicinal products, in which case they are in Class C.
2. they are intended to undergo chemical change in the body (except the medical devices are placed in the teeth), in which case they are in Class C.
3. they are intended to supply energy in the form of ionizing radiation, in which case they are in Class C.
4. they are intended to have a biological effect or be wholly or mainly absorbed, in which case they are in Class D.
5. they are they are intended specifically for use in direct contact with the central nervous system, in which case they are in Class D.
6. they are intended specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class D.
Rule 8. Surgically invasive medical devices intended for long-term use and implantable medical devices
All surgically invasive medical devices intended for long-term use and implantable medical devices are in class C, unless:
1. they are intended to be placed into the teeth, in which case they are in Class B.
2. they are they are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class D.
3. they are intended to be life supporting or life sustaining, in which case they are in Class D.
4. they are intended to be active medical devices, in which case they are Class D.
5. they are intended to have a biological effect or be wholly or mainly absorbed, in which case they are in Class D.
6. they are intended to administer medicinal products, in which case they are in Class D.
7. they are intended to undergo chemical change in the body (except the medical devices are placed in the teeth), in which case they are in Class D.
8. they are breast implants, in which case they are in Class D.
Rule 9. Active therapeutic medical devices
All active therapeutic medical devices intended to administer or exchange energy are in Class B, unless:
1. their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, including ionizing radiation, taking account of the nature, the density and site of application of the energy, in which case they are in Class C.
2. they are intended to control or monitor the performance of active therapeutic medical devices in Class C, or intended directly to influence the performance of such medical devices, in which case they are in Class C.
Rule 10. Active medical devices intended for diagnosis
1. Medical devices used to illuminate the patient’s body with light in the visible or near infra-red spectrum are in Class A.
2. Active medical devices intended for diagnosis are in Class B if:
a) they are intended to supply energy which will be absorbed by the human body; except for those specified in (a);
b) they are intended to image in vivo distribution of radiopharmaceuticals;
c) they are intended to allow direct diagnosis or monitoring of vital physiological processes.
3. Active medical devices intended for diagnosis are in Class C if they are intended for one of the following purposes:
a) monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of central nervous system; or
b) diagnosing in clinical situations where the patient is in immediate danger.
4. Active medical devices intended to emit ionizing radiation and intended for diagnostic and/or interventional radiology, including medical devices which control or monitor such medical devices, or those which directly influence their performance, are in Class C.
Rule 11. Active medical devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body
All active medical devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body are in Class B, unless this is done in a manner that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode and route of administration or removal, in which case they are in Class C.
Rule 12. Other active medical devices
All other active medical devices are in Class A.
D. OTHER RULES
Rule 13. Other active medical devices
All medical devices incorporating a substance which can be considered to be a medicinal product and which is liable to act on the human body are in Class D.
Rule 14. Medical devices of animal or microbial origin
1. Active medical devices are in Class D if they are manufactured from or incorporating:
a) animal cells, tissues and/or derivatives thereof, rendered non-viable; or
b) cells, tissues and/or derivatives of microbial or recombinant origin.
2. Medical devices that are manufactured from or incorporate non-viable animal tissues or their derivatives that come in contact with intact skin only are in Class A.
Rule 15. Medical devices intended to be used for sterilizing or disinfecting
1. Medical devices intended to be used for sterilizing medical devices are in class C.
2. Medical devices intended to be used for disinfecting medical devices as the end point of processing are in Class C.
3. Medical devices intended to be used for disinfecting medical devices prior to end point sterilization are in Class B.
4. Medical devices intended to be used for disinfecting medical devices prior to higher level disinfection are in Class B.
5. All medical devices used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class C.
Rule 16. Medical devices used for contraception or prevention of transmission of sexually transmitted diseases
1. All medical devices used for contraception or prevention of transmission of sexually transmitted diseases are in Class C.
2. Medical devices used for contraception or prevention of transmission of sexually transmitted diseases that are implantable or long-term invasive medical devices are in class D.
Part III
RULES FOR CLASSIFICATION OF IVD MEDICAL DEVICES
Rule 1. IVD medical devices intended for the following purposes are classified as Class D:
1. Medical devices intended to be used to detect the presence of, or exposure to, a transmissible agent in blood, blood components, blood derivatives, cells, tissues or organs in order to assess their suitability for transfusion or transplantation.
2. Medical devices intended to be used to detect the presence of, or exposure to, a transmissible agent that causes a life-threatening, often incurable, disease with a high risk of propagation
Rule 2
IVD medical devices intended to be used for blood grouping, or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation are classified as Class C, except for ABO system [A (AB01), B (AB02), AB (AB03)], rhesus system [RH 1 (D), RH2 (C), RH3 (E), RH4 (c), RH5 (e)], Kell system [Kel1 (K)], Kidd system [JK1 (Jka), JK2 (Jkb)] and Duffy system [FY1 (Fya), FY2 (Fyb)] determination which are classified as Class D.
Rule 3. IVD medical devices are classified as Class C if they are intended for use:
1. in detecting the presence of, or exposure to, a sexually transmitted agent (e.g. Sexually transmitted diseases, such as Chlamydia trachomatis, Neisseria gonorrhoeae).
2. in detecting the presence in cerebrospinal fluid or blood of an infectious agent with a risk of limited propagation (e.g. Neisseria meningitidis or Cryptococcus neoformans).
3. in detecting the presence of an infectious agent where there is a significant risk that an erroneous result would cause death or severe disability to the individual or fetus being tested (e.g. diagnostic assay for CMV, Chlamydia pneumoniae, Methycillin Resistant Staphylococcus aureus).
4. in pre-natal screening of women in order to determine their immune status towards transmissible agents (e.g. Immune status tests for Rubella or Toxoplasmosis).
5. in determining infective disease status or immune status, and where there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient (e.g. Enteroviruses, CMV and HSV in transplant patients).
6. in screening for selection of patients for selective therapy and management, or for disease staging, or in the diagnosis of cancer (e.g. personalized medicine).
Those IVD medical devices where the therapy decision would usually be made only after further investigation and those used for monitoring would fall into Class B under rule 6 - Part III.
7. in human genetic testing (e.g. Huntington’s Disease, Cystic Fibrosis).
8. to monitor levels of medicines, substances or biological components, when there is a risk that an erroneous result will lead to a patient management decision resulting in an immediate life-threatening situation for the patient (e.g. Cardiac markers, cyclosporin, prothrombin time testing).
9. in the management of patients suffering from a life-threatening infectious disease (e.g. HCV viral load, HIV Viral Load and HIV and HCV geno- and subtyping).
10. in screening for congenital disorders in the fetus (e.g. Spina Bifida or Down Syndrome).
Rule 4
1. IVD medical devices intended for self-testing are classified as Class C, except those medical devices from which the result is not determining a medically critical status, or is preliminary and requires follow-up with the appropriate laboratory test in which case they are Class B.
2. IVD medical devices intended for blood gases and blood glucose determinations for near-patient testing would be Class C. Other IVD medical devices that are intended for near patient should be classified in their own right using the classification rules.
Rule 5. The following IVD medical devices are classified as Class A:
1. Other articles that participate in or assist in the testing process, intended by the product owner to make them suitable for IVD procedures related to a specific examination.
2. Instruments intended by the product owner specifically to be used for IVD procedures.
3. Specimen receptacles.
Rule 6. IVD medical devices not covered in Rules 1 through 5 are classified as Class B.
Rule 7. IVD medical devices that are controls without a quantitative or qualitative assigned value will be classified as Class B.
Section 2. GROUPING OF MEDICAL DEVICES
Medical devices can grouped as single medical devices or one of the following grouping categories:
a) Family;
b) In vitro diagnostic (IVD) test kit;
c) System;
d) IVD cluster;
dd) Group;
1. Single medical devices
A single medical device is a medical device from a product owner identified by a proprietary name or brand name with a specific intended purpose and sold as a distinct packaged entity and that cannot be assigned into a family, IVD test kit, system, IVD cluster or group.
2. Family
A medical device family is a collection of medical devices and each medical device family member:
- is from the same product owner;
- is of the same risk classification;
- has a common intended purpose;
- has a common design and manufacturing process; and
- has variations that are within the scope of the permissible variants.
Table 1. List of permissible variants in a family
Specific products |
Permissible variants |
Abutments |
Retention (e.g. cement or screw) |
Active implantable device |
MR conditional and non-MR conditional |
Antibiotic test (IVD) |
Concentration |
Biopsy forceps |
Formable or non-formable |
Blood bags |
(i) Anticoagulants with same composition but different concentrations (ii) Additives (different composition and concentrations) |
Catheter |
(i) Number of lumens in catheter (ii) Material of catheter: PVC (polyvinylchloride), PU (polyurethane), nylon and silicone (iii) Curvature (iv) Coating material for lubrication |
Condoms |
(i) Texture (ii) Flavour |
Contact lens |
(i) Diopter, (ii) UV protection (iii) Tinting (iv) Colour (v) Wearing schedule (i.e daily wear, extended wear) (vi) Replacement schedule (i.e daily, weekly, monthly) |
Defibrillators |
Automatic or semi-automatic |
Dental brackets |
Material of bracket |
Dental handpieces |
(i) Rotational speed (ii) Material of handpiece |
Dermal fillers |
Same composition but different concentrations/densities |
Diagnostic radiographic systems |
(i) Number of slices (ii) Digital or Analog (iii) Biplane and Single Plane (iv) Flat Panel or Cassette (v) PET ring size |
Electrophysiological Catheter |
(i) Electrode spacing (ii) Number of electrodes |
Gloves |
Powdered or powder-free |
Gamma Camera |
Number of detectors |
Guide wire |
With or without inert coating material |
Orthopaedic/dental implants |
(i) Cemented or non-cemented fixation (ii) Collar |
Intra-ocular Lens |
(i) Monofocal or multifocal (ii) Multi-piece or single-piece (iii) Aspheric or spheric |
Implantable pulse generators |
Number of chambers (cardio) |
IV cannula |
(i) Presence of injection port (ii) Presence of safety wing |
IVD rapid tests |
Different assembly format: tray, stick, pen, pipe, midstream, strip |
IVD urinalysis strips |
Different combination of testing configurations |
Polymer products |
With or without plasticizers (e.g. DEHP) |
Stent |
(i) Stent delivery system, that is over-the-wire or through the scope (ii) Flaps, flares or sleeves |
Suture |
(i) Number of strands (ii) Pledgets (iii) Loops (iv) Dyes |
Suture passer |
Design of jaw, handle or needle |
Tracheal tube (endotracheal tube, tracheostomy tube) |
With or without cuff |
Wound dressings |
Different formats (e.g. solution, creams, gels loaded onto pads, etc) |
X-ray detector |
Scintillator material |
Other permissible variants in a family
Coating material for lubrication only |
Colour |
Diameter, length, width, gauge |
Concentration with same indication and mechanism (same composition different amount of constituent) |
Dimensional design differences due to paediatric versus adult use (The differences due to the different patient population are permissible, e.g. volume and length) |
Flexibility |
Holding force |
Isotope activity level |
Memory storage |
Method of Sterilization (to achieve same sterility outcome) |
Printing capability |
Radiopacity |
Shape, size, volume |
Viscosity (The change in viscosity is solely due to changes in the concentration of constituent material) |
Type of device mounting (e.g. ceiling mount, wall mount or standing) |
Sterility status (sterile vs. non-sterile) |
Decision flowchart for grouping of medical devices as a family
3. IVD test kit
An IVD test kit is an in vitro diagnostic (IVD) device that consists of reagents or articles that are:
- from the same product owner;
- intended to be used in combination to complete a specific intended purpose;
- sold under a single test kit name or the labeling, instructions for use for each reagents or article states that the component is intended for use with the IVD test kit; and
- compatible when used as an IVD test kit.
An IVD test kit does not include the instruments, such as analyzers, needed to perform the test. An IVD medical device system may typically consist of test kits and instruments (e.g. an analyzer designed to be used with that test kit).
Individual reagents or articles in the IVD test kit can be supplied separately as replacement items for the kit. If the reagents or articles in an IVD test kit are supplied for use in more than one test kit, such reagents or articles shall be included in the product registration application of each of the other test kits.
Reagents or articles from another product owner may be grouped with the IVD test kit if the applicant furnishes all information on these reagents or articles required for registration, such as authorization from the other product owners for registration and data to substantiate the performance of these reagents when used in the test kit.
Example:
A Human Immunodeficiency Virus (HIV) Enzyme Linked ImmunoSorbent Assay (ELISA) test kit may contain controls, calibrators and washing buffers. All the reagents and articles are used together to detect HIV and therefore can be considered as an IVD test kit. These reagents and articles can be supplied separately as replacement items for that particular test kit.
Decision flowchart for grouping of medical devices as an IVD test kit
4. System
A medical device system comprises of a number of medical devices and/or accessories that are:
- from the same product owner;
- intended to be used in combination to achieve a common intended purpose;
- compatible when used as a system; and
- sold under a single system name or the labeling, instructions for use, brochures or catalogues for each constituent component indicates that the constituent component is intended to be used together or for use with the system.
Devices that are part of a system shall only be supplied specifically for use with that system. Any device that is meant for supply for use with multiple systems should be registered together with each of these other systems or they can be registered separately.
A product owner of a medical device system may incorporate medical devices and/or accessories from other product owners (or manufacturers) as part of their system to achieve the intended purpose of the device.
Example:
A patient monitoring system from product owner A is intended to be used specifically with vital signs sensors and probes from product owner B. These accessories are used in combination to achieve a common intended purpose in accordance with product owner A’s specifications, and can be grouped together with the patient monitoring system in one application for registration.
Decision flowchart for grouping of medical devices as a system
Example on grouping of systems as a family:
Note: the key constituent-components, i.e. implantable rods, plates and screws, across the systems are within the permissible variants. Differences in lengths of the implantable screws are deemed permissible variants.
- A hip replacement system comprising of femoral and acetabular components can be grouped as a system. The components must be used in combination to achieve a common intended purpose of total hip replacement. The size of the components may vary.
- An electrosurgical unit and its accessories that consist of forceps, electrodes, electrode holders, leads, plug adaptor, when used together for a common intended purpose, can be grouped as a system.
- A catheter placement set/kit comprising of scalpels, syringes, needles, surgical gloves, gauze, drapes and flushing solution that is validated for compatibility and assembled by a single product owner under a single system name for use in combination during a surgical catheter placement procedure can be grouped as a system.
- Automated blood pressure monitors with optional features such as memory storage and print capability for various models can be considered as part of a family of systems.
5. IVD cluster
An IVD cluster comprises of a number of in vitro diagnostic reagents or articles that are:
- from the same product owner;
- is of the same risk classification (either Class A only or Class B only);
- of the same IVD cluster category and a common test methodology as listed in Table 2; and
The IVD cluster may include analyzers that are designed for use with the reagents in the IVD cluster.
Table 2. List of common test methodologies and IVD cluster categories
No. |
Methodology |
Cluster category (closed list) |
Examples of analytes |
|
1 |
Clinical Chemistry |
Enzymes |
(i) Acid Phosphatase (ii) Alpha-Amylase (iii) Creatine Kinase (iv) Gamma-Glutamyl Transferase (v) Lactate Dehydrogenase (vi) Lipase |
|
2 |
Substrates |
(i) Albumin (ii) Bilirubin (iii) Urea/Blood Urea Nitrogen (iv) Cholesterol (v) Creatinine (vi) Glucose |
||
3 |
Electrolytes reagents |
(i) Ammonia (ii) Bicarbonate (iii) Calcium (iv) Chloride (v) Magnesium (vi) Phosphate Inorganic/Phosphorus |
||
4 |
Electrolytes electrodes |
(i) Ammonia electrodes (ii) Carbon Dioxide (Bicarbonate) electrodes (iii) Calcium electrodes (iv) Chloride electrodes (v) Magnesium electrodes (vi) Potassium electrodes |
||
5 |
Substrate electrodes/biosensors |
(i) Creatinine electrodes (ii) Glucose electrodes (iii) Glycated Hemoglobin electrodes (iv) Lactate electrodes (v) Urea electrodes (vi) Bilirubin electrodes |
||
6 |
Immunochemistry |
Immunoglobulins (without IgE) |
(i) Immunoglobulin A (ii) Immunoglobulin D (iii) Immunoglobulin G (iv) Immunoglobulin M (v) Immunofixation kits |
|
7 |
Complement components |
(i) Complement component C1q (ii) Complement component C1 inactivator (iii) Complement component C3/C3c (iv) Complement component for Bb (v) Complement component C4 (vi) Complement component C5a |
||
8 |
Transport proteins |
(i) Albumin (ii) Ceruloplasmin (iii) Haptoglobin (iv) Hemopixin (v) Lactoferrin (vi) Pre-albumin/Transthyretin |
||
9 |
Lipoproteins |
(i) Apolipoprotein A I (ii) Apolipoprotein A II (iii) Apolipoprotein B (iv) Apolipoprotein E Sub-typing (v) Lipoprotein (a) |
||
10 |
Other specific proteins |
(i) a1-Acid Glycoprotein (ii) a1-Antitrypsin (iii) a1-Microglobulin (iv) Fibronectin (v) Immuno Reactive Trypsin |
||
11 |
Allergy |
(i) Immunoglobulin E - Total (ii) Immunoglobulin E - Screen (iii) Immunoglobulin E – Specific, monotest/monoresult (iv) Allergen specific IgA (v) Allergen specific IgG |
||
12 |
Cancer markers |
(i) GI-marker CA242 (ii) p53 |
||
13 |
Thyroid function markers |
(i) Free triiodothyronine (ii) Free thyroxine (iii) Thyroid stimulating hormone (iv) T - Uptake (v) Thyroglobulin (vi) Neonatal Thyroxine |
||
14 |
Fertility/pregnancy hormones/proteins |
(i) Androstenedione (ii) Estradiol (iii) Prolactin (iv) Human placental lactogen (v) Estriol |
||
15 |
Diabetes assays (hormones) |
(i) C-Peptide (ii) Melatonin (iii) Insulin (iv) Glycosylated/Glycated Haemoglobin (v) Islet Cell Ab (vi) Proinsulin |
||
16 |
Renal metabolism assays |
(i) Aldosterone (ii) Angiotensin I / II (iii) Angiotensin-converting enzyme (iv) Cortisol (v) Renine |
||
17 |
Bone and mineral metabolism assays |
(i) Bone alkaline phosphatase (ii) Calcitonin (iii) Cross-linked C-Telopeptides (iv) Cross-linkded N-Telopeptides (v) Cyclic Adenosin Monophosphate (vi) Hydroxyproline |
||
18 |
Endocrine Hormones and Peptides |
(i) Adrenocorticotropic Hormone (ii) Human Growth Hormone (iii) Insulin-like growth factor I (iv) Insulin-like Growth Factor Binding Protein 1 (v) Vasointestinal Peptide (vi) Vasopressin |
||
19 |
Neuroendocrine function assays |
(i) Bombesin (ii) 17-Hydroxy-Ketosterone (iii) β-Endorphin (iv) Proinsulin (v) Somatostatin (vi) Substance P |
||
20 |
Other individual and specified hormones |
(i) Gastrin (ii) Gonadotropin-releasing hormone (iii) Melatonin (iv) Pepsinogen (v) Adrenalin (vi) Dopamine |
||
21 |
Anaemia |
(i) Erythropoietin (ii) Ferritin (iii) Folate (iv) Iron (v) Iron binding capacity (vi) Soluble transferrin receptor |
||
22 |
|
Vitamins |
(i) Vitamin B1 (ii) Vitamin B2 (iii) Vitamin B6 (iv) Vitamin B12 (v) Vitamin D (Cholecalciferol) (vi) Intrinsic factor (Blocking antibody) |
|
23 |
Drug monitoring |
(i) Caffeine (ii) Benzodiazepines (iii) Penicillins (iv) Tetracyclines |
||
24 |
Toxicology |
(i) Amphetamines (ii) Cocaine (iii) Morphines (iv) Phencyclidine (v) Acetaminophen (vi) Catecholamines (vii) Ethanol (viii) Salicylate |
||
25 |
Auto-immune diseases |
(i) Anti-nuclear antibodies (ANAs) (ii) Anti-topoisomerase (iii) Organ-specific autoantibodies (iv) Circulating Immuno-complex (v) TSH Receptor antibodies (vi) Anti-Cardiolipin antibodies |
||
26 |
Rheumatoid-inflammatory diseases markers |
(i) Anti-Streptococcal Hyaluronidase (ii) Anti-Streptokinase (iii) Anti-Streptolysin O (iv) C-Reactive Protein (v) Anti-Staphylolysin (vi) Anti-Streptococcal Screening |
||
27 |
Liver function |
(i) MEGX (ii) Carbohydrate Deficient Transferrin |
||
28 |
Cardiac markers |
(i) Homocysteine (ii) pT2 (iii) Galectin-3 (iv) Myeloperoxidase (MPO) |
||
29 |
Bacterial infection - Immunology |
(i) Bacillus subtilis (ii) Pseudomonas Aeruginosa (iii) Helicobacter Pylori (iv) Lactobacillus casei |
||
30 |
Viral infection - Immunology |
(i) Norovirus (ii) Rotavirus (iii) Hantavirus |
||
31 |
Parasitic infection – Immunology |
(i) Leishmania |
||
32 |
Fungal infection - Immunology |
(i) Candida albicans (ii) Aspergillus |
||
33 |
Histology/Cytology (Blood tests for transfusions excluded) |
Hemoglobin testing |
(i) Hemoglobin determinations (ii) Fractional oxyhemoglobin (FO2Hb) (iii)Fractional carboxyhemoglobin (FCOHb) (iv) Fractional methemoglobin (FMetHb) (v) Fractional deoxyhemoglobin (FHHb) |
|
34 |
General coagulation tests |
(i) Prothrombin time (ii) Thrombin time (iii) Activated clotting time (iv) Activated partial thromboplastin |
||
35 |
Haemostasis (Coagulation) |
(i) Fibrinogen (ii) Protein C and Protein S reagents (iii) C1 inhibitors (iv) Alpha-Antiplasmin (v) Fibrin (vi) Factor XIII (vi) Platelet Factor 4 (vii) Plasminogen |
||
36 |
Other hematology tests |
(i) Complete blood count (ii) Hematocrit (ii) Erythrocyte sedimentation rate |
||
37 |
Cytokines (Lymphokines)/ Immunomodulators |
(i) Interferons (ii) Soluble antigens/Receptors (iii) Tumor necrosis factors (iv) Colony stimulating factors (vi) Tumor Necrosis Factors receptors |
||
38 |
Histology/Cytology reagent |
(i) Cytochemical staining (ii) Embedding, fixing, mounting media (iii) Stain solution (iv) Immunohistology kits |
||
39 |
Culture media |
(i) Dehydrated culture media (DCM) (ii) Additives for DCM (iii) Prepared media (tubes, bottles, plates) (iv) Cells, media, serum for viral culture |
||
40 |
Testing for the susceptibility of the bacteria to certain antibiotics |
(i) Erythromycin susceptibility test for Staphylococcus aureus (ii) Tobramycin susceptibility test for Pseudomonas aeruginosa (iii) Fungal susceptibility testing |
||
41 |
Biochemical culture Identification (ID) |
(i) Gram Negative Manual ID (ii) Gram Positive Manual ID (iii) Other ID Kits Manual - Anaerobes, Fastidious |
||
42 |
Immunological culture Identification (ID) |
(i) Streptococci Grouping Slide tests (ii) Serotyping (E.coli, Salmonella, Shigella, etc.) |
||
43 |
Nucleic Acid (NA) based culture identification (ID) |
(i) Streptococci (ii) Shigella |
||
44 |
Serological identification (ID) |
(i) For Parasitology and Mycology |
||
45 |
Bacterial infections (Detection by NA Reagents) |
(i) Streptococci (ii) Shigella |
||
46 |
Viral Infections (Detection by NA Reagents) |
(i) Para-influenza NA Reagents |
||
47 |
Fungal infections |
(i) Fungi NA Reagents (ii) Candida albicans (iii) Aspergillus |
||
Decision flowchart for grouping of medical devices as an IVD cluster
If a reagent or article is intended for multiple usage categories, it can be grouped into more than one IVD cluster.
Example of a Class B IVD cluster grouping with 4 products within the Cluster category - Enzymes
Example: Product owner is “DMEC”
Based on the example, the 04 IVD products qualify to be submitted as one IVD cluster category (Enzymes) and would be listed as follows:
1. DMEC ABC Test Kit for Enzyme A*
2. DMEC ABC Test Kit for Enzyme B**
3. DMEC ENZ Test Kit for Enzyme B***
4. DMEC ENZ Test Kit for Enzyme C****
* DMEC ABC Test Kit for enzyme A is under one listing in which DMEC is the product owner and ABC is the proprietary name.
I* DMEC ABC Test Kit for enzyme B is under one listing in which DMEC is the product owner and ABC is the proprietary name.
*** DMEC ENZ Test Kit for enzyme B is under one listing in which DMEC is the product owner and ENZ is the proprietary name.
**** DMEC ENZ Test Kit for enzyme C is under one listing in which DMEC is the product owner and ENZ is the proprietary name.
6. Other medical device groups
A group of medical devices is a collection of two or more medical devices other than IVD medical devices that is labeled and supplied in a single packaged unit by a product owner. The medical device group comprises of the following:
- a single proprietary name of the group;
- labeled and supplied in a single packaged unit by the product owner; and
- a common intended purpose.
This list of medical devices in a group may differ in the number (quantity) and combination of products that comprise the group, while maintaining the same proprietary name and intended purpose of the group.
A product owner of the group assumes responsibility for the group and its intended purpose. The product owner of a medical device group may incorporate medical devices obtained from other manufacturers/product owners as part of their group to achieve the common intended purpose. In manufacturing and assembling this group of medical devices, the evidence to substantiate the safety, quality and efficacy of the collection of devices shall be provided in the submission. Relevant information for submission may include sterility, shelf life, evidence on use and compatibility as a group, quality management systems, etc. Labeling, particularly the instructions for use (IFU), where applicable, shall clearly describe the common intended purpose of the group.
Medical devices that are registered within a group must have a single medical device registration before they are sold separately as individual medical devices for their specific individual intended purpose or as replacements.
If a medical device in a group is supplied for use in another group, such a medical device shall be included in the registration application of that other group.
The group name indicated for the medical device must appear in the product label affixed on the external package of the group. The content list of devices in the group must appear on the external package of the group or supplied with the group.
Example:
- A first aid group consisting of medical devices such as bandages, gauzes, drapes and thermometers, when assembled together as one package for a common medical purpose by a product owner, can be registered as a group.
- A product owner supplies dressing trays customized with different quantity and type of gauze and sutures to different hospitals. When the medical devices in the group are registered, the product owner is able to customize the trays, from the list of devices, for other hospitals, while maintaining the same group name for the trays and the registered intended purpose. The product label for the trays shall bear the content list of devices within the package for supply. Some of the medical devices in the group may be individually packaged and labeled, while others remain in bulk form and may not be labeled.
- A promotional pack or convenience pack, without a group name and without a common intended medical purpose, consisting of different number of medical devices, for example multi-purpose solution, saline solution, and contact lens case, will not qualify as a group registration. Individual medical devices shall require registration as single medical devices.
Decision flowchart for grouping of medical devices as a group
APPENDIX II
(Promulgated together with Circular No. 05/2022/TT-BYT dated August 01, 2022 of the Minister of Health)
NAME OF FACILITY |
SOCIALIST REPUBLIC OF VIETNAM |
No. …..… |
…1..,..... |
MEDICAL DEVICE CLASSIFICATION SHEET
Pursuant to the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices;
Pursuant to Circular No. ... /2022/TT-BYT dated ... elaborating the Government’s Decree No. 98/2021/ND-CP dated November 08, 2021 on management of medical devices.
Below is our classification of medical devices:
No. |
Name of medical device |
Category/code |
Manufacture, country of origin |
Manufacturer, owner's nationality |
Owner's intended uses |
Basis for risk classification |
Risk classification |
|
|
|
|
|
|
|
|
|
Legal representative of the
facility |
____________________________
1 Location