Decree 07/2023 Updates Medical Device Regulations
On March 3, 2023, the Government of Vietnam issued Decree No. 07/2023/ND-CP, amending and supplementing a number of provisions of Decree No. 98/2021/ND-CP on the Management of Medical Devices. The Decree took effect on the date of issuance and introduced several important changes to the regulatory framework for placing and managing medical devices in Vietnam.
One of the key amendments concerns the definition of the marketing authorization holder. Under the revised provisions, the holder is the organization that declares the applicable standards for a medical device or is issued a certificate of registration for the device in accordance with Decree No. 98/2021/ND-CP.
The Decree also revises the conditions for placing medical devices on the market. A device must generally have an appropriate registration number, marketing authorization number, registration certificate, or import license, depending on the applicable regulatory pathway. In addition, the device must meet labeling requirements and have instructions for use provided in Vietnamese.
Another important area addressed by Decree No. 07/2023/ND-CP is the continued application of transitional provisions concerning the circulation, importation, registration, and use of medical devices. These provisions were introduced to help ensure regulatory continuity while the medical device management framework under Decree No. 98/2021/ND-CP was being implemented.
The amendments are particularly relevant to manufacturers, importers, distributors, registration holders, and other organizations involved in the supply of medical devices in Vietnam. Understanding the revised requirements is essential for maintaining regulatory compliance, preparing appropriate documentation, and ensuring that medical devices can be legally placed on the Vietnamese market.
For international manufacturers and suppliers, Decree No. 07/2023/ND-CP represents an important update to Vietnam’s medical device regulatory framework and should be considered when planning market entry, product registration, importation, and distribution activities.
Labomed Vietnam provides this legal reference to support manufacturers, suppliers, and international partners in understanding Vietnam’s evolving medical device regulatory requirements.
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