The process of medical devices registration in Vietnam is overseen by the Department of Medical Equipment and Construction (DMEC), operating under the Ministry of Health (MOH). The regulatory landscape for registration is currently undergoing significant changes, with the introduction of Decree No. 98/2021, replacing previous regulations.
As of January 1, 2022, Decree No. 98/2021 has come into effect, signaling a transition period for compliance. However, there’s a notable scarcity in the issuance of Market Authorization (MA) Licenses for Class C and D products since the implementation of the new decree. Additionally, previously issued Import Licenses have been extended until December 31, 2024, as per Decree 07/2023.
For companies engaging in the export of medical devices to Vietnam, it’s crucial to stay abreast of these regulatory changes and ensure compliance with the updated requirements. Adhering to the new regulations is essential to navigate the registration process smoothly and maintain market access for medical devices in Vietnam.
In Vietnam, the registration of medical devices is governed by specific regulations, with certain criteria for eligibility. Only local companies with a valid Establishment License from the Local Department of Planning and Investment are authorized to register medical devices. These organizations include Vietnamese enterprises, cooperatives, household businesses owning or trading medical devices, and standing representative offices of foreign traders with ownership or authorization of medical devices.
For foreign manufacturers seeking registration in Vietnam, there are several avenues available:
In Vietnam, medical device registration follows a classification system aligned with GHTF guidelines, ranging from Class A to Class D based on risk level. Previously, classification required local certification, but now the Registration Holder can classify the product within the application process.
| Class | DMEC Fees / MA Licenses | Timeline |
|---|---|---|
| Class A | VND 1 million (~US$44) | 7-10 working days |
| Class B | VND 3 million (~US$130) | 7-10 working days |
| Class C | VND 6 million (~US$245) | 6-12 Months |
| Class D | VND 6 million (~US$245) | 6-12 Months |
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 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. However, 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.
Ensuring compliance with these documentation requirements is essential for successfully registering medical devices in Vietnam. Each document plays a crucial role in demonstrating the safety, quality, and efficacy of the device, ultimately facilitating market access and regulatory approval.
| Document Name | Class A | Class B | Class C | Class D |
|---|---|---|---|---|
| Executive Summary | Yes | Yes | ||
| Device Description | Yes | Yes | Yes | Yes |
| Labelling and IFU | Yes | Yes | Yes | Yes |
| Risk assessment | Yes | Yes | ||
| PMS report | Yes | Yes | ||
| Declaration of conformity | Yes | Yes | ||
| Summary of Design V&V | Yes | Yes | ||
| Summary of clinically testing data | Yes | Yes | ||
| Essential Principles and methods | Yes | Yes | ||
| Physical Manufacturer Information | Yes | Yes | Yes | Yes |
