Vietnam Medical Device Registration And Approval | Asia Actual LLC

Regulatory Pathway in Vietnam

The first step toward regulatory compliance in Vietnam is to classify the product in accordance with its intended use and risk level. Under the previous regulations, the classification needed to be performed by a certified Classification Agent but under the new rules, the Registration Holder is permitted to classify the product.

Beginning January 1, 2022, all Class A and B products will require a Market Authorization (MA) License. Class A and B devices will undergo a quick administrative review by the Health Department of the province where the Registration Holder is located. The registration number will be issued immediately and significantly reduces the review time for Class B devices from 60 days.

Regulatory Requirements for New Medical Devices

The current application requirements consist of administrative documents only (no technical file). Documentation for all Class devices may be submitted in Vietnamese or English until at least January 1, 2025. Some documents like the IFU and Technical Summary will need to be in Vietnamese while others like the Letter of Authorization will need to be Legalized. Eventually, manufacturers will need to submit their application in the Common Submission Dossier Template (CSDT) format.

MA Licenses do not expire under the new Decree.

Class A and B Medical Devices

Class A and B devices are subject to a Notification process that is overseen by the provincial offices of the MOH. By handling these administrative reviews, the central MOH has more time to focus on Class C and D applications. Class A and B MA License applications that leverage Reference Country approval are typically approved within 1 week.

Class C and D Medical Devices

Class C and D devices listed in Circular 30/2015 required an Import License or Market Authorization (MA) License prior to importing and marketing in Vietnam. Existing Import Licenses will now expire on June 30, 2025 (link) while MA licenses will remain valid indefinitely. A full list of products found in Circular 30/2015  can be found further below and include ventilators, infant incubators, pacemakers, x-ray machines, MRIs, hemodialysis devices, etc.

Class C and D devices not listed in Circular 30 can continue to be freely imported through June 30, 2025 with only a classification document. This being said, manufacturers of these products are encouraged to obtain a MA License at their earliest convenience.

Products with a Reference Country approval or the same national standards will avoid the Technical Review and we planned to be approved in about 20 working days. Howvever, the MOH has experienced significant delays and have only approved a very limited amount of Class C/D MA Licenses. Class C and D applications without a Reference Country approval or national standards will need to undergo a Technical Review which could take up to 90 days.

Note: As of January 2025, more and more Class C and D applications are being approved, showing a positive trend in clearing the backlog of pending applications. More information on this can be found in our article on the topic here.

Class C and D Products That Require Registration in Vietnam

The following Class C and D devices require an Import License or MA License to be sold in Vietnam. Class C/D devices not listed below and found in Circular 05/2022 can be imported until June 30, 2025 with only a classification document.

The products listed in Circular 05/2022 include:

1. 1. X-ray imaging equipment
   2. Magnetic resonance systems
   3. Diagnostic ultrasound machine
   4. Diagnostic endoscopy system
   5. Cyclotron system
   6. Radioisotope diagnostic equipment (system PET, PET/CT, SPECT, SPECT/CT, device for measuring iodine concentration I 130 , I 131 )
   7. Automatic refractometer, cornea
   8. Electrophysiological machine (electrical machine, electrocardiogram machine, electromechanical machine)
   9. Electroretinometer
   10. Osteoporosis meter
   11. Fundus tomography machine; fundus fluoroscopy machine
   12. Ultrasound fetal heart rate monitor
   13. Respiratory function analyzer/meter
   14. Biochemistry analyzer; electrolyte and blood gas analyzer
   15. Hematology analyzer; blood group analyzer
   16. Coagulation meter; erythrocyte sedimentation rate meter
   17. Elisa test system
   18. Cell extractor
   19. Platelet aggregation and function analyzer
   20. Bacterial and virus identification machine
   21. Immunoassay machine
   22. In vitro reagents, calibrators, and control materials
   23. X-ray treatment equipment
   24. Laparoscopic surgery system
   25. Radiation therapy equipment (cobalt machine for cancer treatment, linear accelerator for cancer treatment, gamma scalpel of all kinds, Brachytherapy equipment of all kinds)
   26. Patient monitor
   27. Infusion pump; electric injection pump
   28. Scalpel (high frequency electricity, laser, ultrasound).
   29. Surgical microscope
   30. Prostate surgery equipment system
   31. Artificial heart-lung machine
   32. Positioning device in surgery
   33. Cryosurgery equipment
   34. Newborn incubators; baby warmer
   35. Anesthesia/anesthesia machine with breathing apparatus
   36. Ventilator
   37. Defibrillator, pacemaker
   38. High pressure oxygen chamber
   39. Extracorporeal lithotripsy/endoscopic lithotripsy system
   40. System of high-intensity ultrasound equipment for tumor treatment
   41. Dialysis equipment
   42. System of specialized ophthalmic surgery (Laser Excimer, Phemtosecond Laser, Phaco, Vitreous cutter, Corneal flap cutter)
   43. Eyeglasses, contact lenses (nearsightedness, farsightedness, astigmatism) and contact lens preservation solution
   44. Laser machine for ophthalmology
   45. Long-term (over 30 days) implantation of devices and materials into the body, like Dental implants
   46. Types of equipment and materials for intervention in the body of cardiology, cranial nerves

Additional Regulatory Notes

Vietnam has special labeling requirements for registered medical devices including the registration number and License Holder contract information.  Complaint labeling may be affixed after Customs clearance.

Exemptions from the registration process are made for products used for RUO, testing, training, repair, exhibition, or donated devices

Price Declaration Process

Also updated by Decree 07/2023 was the Price Declaration process. Previously, all devices needed to be list and the License Holder was required to list the price on behalf of the manufacturer. Now, only the actual trading company is required to list the products on the public portal and only a specified list of products need to be listed.

Please see a brief table outlining the recent updates:

Price Declaration Updates	Decree 98/2021 (01 April 2022- 02 March 2023)	Decree 07/2023 (03 March 2023 – Present)
Responsible Party	License holder	Trading company
Medical devices	All medical devices	Only those on the MOH’s list
Hospital tenders	Required to sell or buy under Price Declaration	Only those on the MOH’s list

Quality Systems Conformity Assessment

A Quality Systems Conformity Assessment is required for Class B, C and D devices and can be demonstrated with an ISO 13485. 

Expedited Review for Reference Country Approval

The MOH has also updated the expedited review process for medical devices with at least 1 Reference Country approval, which includes the USA, Canada, Europe, Japan, or Australia. As part of 98/2021, the MOH extended acceptable Reference Country approval to China’s NMPA and Korea’s MFDS. Products with an approval from at least one of these markets will still need to submit the required documentation (technical summary, label, IFU, brochure until Dec. 31, 2024, then CSDT) but will not undergo a technical dossier evaluation which intends to shorten the wait time from 60 working days to 10. Expedited review has not officially begun for Class C and D applications.

Additionally, to help manufacturers already on the market make a smooth transition to MA licenses, the MOH will also allow waive technical reviews for Class C and D for products with an Import License. More information available here & here.