Vietnam

Medical Device Registration in Vietnam

Government Authority

Medical Device regulation in Vietnam is administered by the Department of Medical Equipment and Construction (DMEC), under the Ministry of Health (MOH). Medical Device registration requirements in Vietnam are currently in a state of transition.

New rules governing the registration of medical devices were published on November 8, 2021 with Decree No. 98/2021. This new Decree overrules previous Decree No. 36/2016/ND-CP as amended with Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP. Implementation for the new rules will begin January 1, 2022 with a 1-year transition period for documentation and some Class C and D products. However, since the implementation of 98/2021, very few Class C and D Market Authorization (MA) Licenses have been issued and previously issued Import Licenses have had their validity auto-extended to December 31, 2024 via Decree 07/2023. You can read more about the latest decree here.

Important Medical Device Regulations in Vietnam

Decree No. 98/2021/ND-CP – effective Jan 1, 2022

Decree No. 111/2021 – Amends Decree No. 43/2017 and Updates Labeling requirements

Circular 05/2022 – Provides a list of products that require registration prior to importation.

Decree 07/2023 (EN/VN)- Extends the validity of Import Licenses and delays implementation of CSDT application requirements, as well as additional clarifications. You can read more about this decree here.

Previous Governing Regulations

Circular No. 30/2015/TT-BYT – effective since 2015 and will transition out by Dec 31. 2022

Decree No. 36/2016/ND-CP–effective Jan 1, 2020 and now overruled by Decree 98/2021

Decree No. 169/2018/ND-CP – amended Decree 36 adds fast track approval; and CSDT requirement (now overruled by Decree 98/2021)

Decree No. 03/2020/ND-CP – amended Decree 36 details implementation process of new Rules (now overruled by Decree 98/2021)

Medical Device Status

In Vietnam, Medical devices are any equipment, tools, materials and chemicals, necessary software, used alone or in combination that aim to prevent, examine, diagnose and/or mitigate illness or check, replace, modify or offer surgical support during examinations and treatment.

Under new rules, Software is considered a medical device.

Product Classification

Vietnam closely follows GHTF guidelines for medical device classification with Class A, B, C and D devices, ranging from low to high risk. Previously, medical device risk classification in Vietnam had to be determined by a locally certified organization or person but under the new regulations, the Registration Holder can classify the product as part of the application.

	DMEC Fees / MA Licenses	Review Time
Class A	VND 1 million (~US$40)	Immediate
Class B	VND 3 million (~US$120)	Immediate
Class C	VND 6 million (~US$240)	Target: 10 to 90 days Actual: 1 or more Years
Class D	VND 6 million (~US$240)	Target: 10 to 90 days Actual: 1 or more Years

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 (updated in March 2023). 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 December 31, 2024 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 December 31, 2024 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 March 2023, very few Class C or D MA Licenses have been issued. Please see our article on Decree 07/2023 outlining the extension of Import License validity and delay of CSDT documentation.

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 freely imported until December 31^st, 2024.

The products listed in Circular 05/2022 include:

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 13485:2016.

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.

Reference Countries

Australia – Canada – European Union – Japan – United States – China – Korea

Advertising Requirements

Per Article 62 of Decree 98/2021 and implemented in July of 2022, ALL advertising material (e.g., print, internet, or video), including materials for Direct to Consumer (DTC) and healthcare professionals must be uploaded to the public portal. Once uploaded, a unique number is provided which then needs to be included in the advertising materials when placed on the market. Under this new plan, advertisements may be removed from the market if they’re found to not meet the MOH’s requirements. There is no fee for uploading materials to the portal.

Advertising materials must contain the following information:

Name of medical equipment, type, product code, manufacturer, manufacturing country;
Circulation number;
feature, the effect;
Name and address of the license holder of the free-sale registration number or the organization authorized by the holder of the free-sale registration number of the medical equipment;
Warnings related to users’ health and storage conditions (if any).

Exceptions

Materials meeting any of the following descriptions do not need to be uploaded to the public portal.

Do not refer to the medical device name;
Only list names and technical specifications of medical equipment but have no information on features and effects;
Scientific research papers;
Clinical documentation;
Training materials supporting product manuals.

Validity and Renewal

Once issued, an MA License does not expire. All Import Licenses expire on December 31, 2022.

License Holder Requirements

Medical device manufacturers must appoint, and grant Power-of-Attorney to a local, registered company in Vietnam to submit registration applications and act as the Registration Holder. Under the new regulations, Registration Holders can authorize an unlimited number of distributors to import under the MA License, as well as participate in public tenders.

David Vo, General Manger, Asia Actual Vietnam

“While the new medical device regulations are transitioning, it can be difficult to understand what requirements apply when. We can help.”

Contact Us

US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: VietNam@asiaactual.com

Frequently Asked Questions

Who can submit submit applications in Vietnam?

A local entity must submit applications, hold the license, and correspond with the Ministry of Health. License Holders can then authorize an unlimited number of importers or distributors.

How are products classified in Vietnam?

Medical devices are classified into 4 categories according to GHTF guidelines; from low-risk Class A to high-risk Class D.

How long does it take to register my medical device in Vietnam?

Class A and B are immediately listed and Class C and D applications require 30 to 60 days.

How much does it cost to register my device in Vietnam?

Class A fees are about US$45 and Class D are about US$220.

How long are medical device licenses valid in Vietnam?

Medical device licenses do not expire in Vietnam.

Does the license holder need to be a part of the importing process?

No, license holders can authorize multiple importers to import under one license.

Is there an expedited review pathway?

Yes, Class C and D products approved by a reference country will be reviewed in half the time. Reference Countries in Vietnam include: USA, Canada, Europe (incl. UK and Switzerland), Australia, Japan, China, and South Korea.

Is ISO 13485 required for medical devices in Vietnam?

Yes, ISO 13485 is required for registration in Vietnam.

Is Home Country approval required?

No, there are no requirements for home country approval. Reference country approval will significantly improve the review time.

Do documents need to be translated to Vietnamese as part of the application process?

Yes, some application documents will need to be translated including the Instructions for Use (IFU) and the labeling.

Benefits of Independent License Holding through Asia Actual

Under the new Vietnamese regulations, manufacturers can use 1 License Holder that can then authorize an unlimited number of local distributors that can then import directly and participate in tenders.

Sell directly to multiple regional distributors, avoiding mark-up by a national importer
Increase transfer pricing
Centralize public pricing strategy
Improve leverage in distributor negotiations/responses
Add or change distributors as required
Keep intellectual property away from local commercial agents
Assure expert handling of post market vigilance and license maintenance

Contact Asia Actual for a free consultation discussing the potential for your medical device or IVD in the Vietnamese market. Asia Actual is available to help navigate the complex medical device registration requirements and regulatory pathway for medical device and IVD distribution in Vietnam.