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- To register a Class B medical device with the Vietnam Ministry of Health (MOH), you must submit a registration dossier through the official MOH portal. Below is a detailed breakdown of the required documents and how to prepare them.
- Here’s a complete guide to the procedures, required documents, and precautions for registering a Class B medical device with the Vietnam Ministry of Health (MOH) under Decree 98/2021/ND-CP and Decree 07/2023/ND-CP.
- To apply for Class B medical device registration in Vietnam, you must submit your application online through the official portal of the Vietnam Ministry of Health (MOH).
- Class B devices are registered through a notification system (no technical review), and currently no official MOH fee is charged for submitting the notification via the MOH portal.
- To register Class B medical devices with the Vietnam Ministry of Health (MOH), you must meet a specific set of regulatory and documentation requirements under Decree 98/2021/ND-CP and its amendment Decree 07/2023/ND-CP.
- 2025-04-07The process and procedure for registering Class B medical devices with the Vietnam Ministry of Health (MOH) follows the regulatory framework outlined in Decree 98/2021/ND-CP and its amendments (notably Decree 07/2023/ND-CP).
- Class B medical devices include general diagnostic and monitoring equipment, surgical instruments, certain infusion sets, wound care products, etc.
- To apply for Class B medical device registration with the Ministry of Health (MOH) in Vietnam, you must follow the procedures outlined under Decree 98/2021/ND-CP (and its amendments, e.g., Decree 07/2023/ND-CP).
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