VN(MOH) - Wiselink Group-A More Controllable, Stable, and Future-Oriented Material Direction

Vietnam Medical Device Regulatory Authority

The core regulatory framework for medical devices in Vietnam is based on Decree No. 98/2021/ND-CP issued by the Ministry of Health, along with subsequent supplementary guidance. This framework implements a relatively simplified registration process for Class A and Class B medical devices. In practice, while the process is simplified, attention must still be paid to the completeness and accuracy of documentation to avoid delays in approval due to minor omissions. The registration of Class C and Class D medical devices differs fundamentally in nature, process, and depth from that of Class A and Class B devices. The core requirement is that applicants must submit complete registration dossiers directly to the medical device regulatory authority under the Ministry of Health (MOH) and undergo a rigorous technical review.

Regulatory Authority Official Website Link:https://imda.moh.gov.vn/web/guest/trangchu

Database Link: https://imda.moh.gov.vn/web/guest/van-ban-cong-bo

Regulatory Framework

Decree No. 98/2021/ND-CP – Effective from January 1, 2022
Decree No. 111/2021 – Amending Decree No. 43/2017 and updating labeling requirements
Circular No. 05/2022 – Providing the list of products requiring registration prior to importation
Decree No. 07/2023 (EN/VN) – Extending the validity of import permits, delaying the implementation of CSDT dossier requirements, and providing other instructions

Risk Classification of Medical Devices and IVD Products

1. Medical Devices

2. IVD

Registration Basis

Vietnamese regulations do not require prior registration of products in other countries as a prerequisite for market access. However, regardless of the risk classification level of the medical device, a Free Sales Certificate (FSC) must be provided as a mandatory document when submitting a registration application.

Authorized Representative

According to Vietnamese regulations, the Marketing Authorization (MA) for a medical device must be held by a locally incorporated company legally registered in Vietnam. Foreign manufacturers must appoint such a local company as their MAH (Marketing Authorization Holder), which shall be fully responsible for the product registration application and all matters with the regulatory authorities.

Admission Prerequisites

ISO 13485
Free Sales Certificate (FSC)

Language Requirements for Registration

English + Vietnamese

Registration Process, Timeline and Official Fees

1. Registration Process

2. Registration Timeline and Official Fees

Circular 64/2025/TT‑BTC from Ministry of Finance & Circular 645/TB‑HTTB from Ministry of Health: All medical device review fees are charged at 50% of the original rate from July 1, 2025 to December 31, 2026. Full original fees will apply starting from 2027.

Service Item	Original Fee (VND)	Promotional Fee 2025.7‑2026.12 (VND)	Description
Class A Standard Publication Registration	1,000,000	500,000	Low‑risk gloves, gauze, etc.
Class B Standard Publication Registration	3,000,000	1,500,000	Medium‑risk monitors, general consumables
Class C/D New‑product Marketing Registration Certificate	6,000,000	3,000,000	High‑risk implants, IVD, large‑scale equipment
Review for Medical Device Import License	2,000,000	1,000,000	Single‑batch import qualification review
Review for Medical Device Export License	1,000,000	500,000	Export customs clearance permit

Packaging Requirements

IFU (Instructions for Use), packaging, and labels must be provided in Vietnamese.

Fill Form

Whether you need more information or wish to cooperate with us, we will guide you through every step of the regulatory process. Subscribe to our newsletter for the latest global regulatory updates.