Tiếng Việt
On June 16, 2026, the Ministry of Health (MOH) issued Official Letter No. 4438/BYT-HTTB, requesting provincial and municipal Departments of Health to strengthen inspection and post-market compliance reviews of medical device administrative procedures in accordance with Decree No. 98/2021/ND-CP and Decree No. 148/2025/ND-CP.
The compliance review activities will focus on procedures managed through the national Medical Device Management System, including:
✔ Declaration of eligibility for medical device manufacturing;
✔ Declaration of applicable standards for Class A and Class B medical devices;
✔ Declaration of eligibility for trading Class B, C, and D medical devices;
✔ Declaration of narcotic and precursor substance concentrations used in medical device manufacturing materials;
✔ Issuance of Certificates of Free Sale (CFS) for Class A and Class B medical devices.
The review scope extends beyond administrative documentation and focuses on compliance throughout the entire lifecycle of medical devices, including:
🔹 Verification of the completeness, validity, and legal status of submitted dossiers;
🔹 Review of technical documentation, intended use, indications for use, instructions for use (IFU), labeling, clinical evaluation reports, and legal documents for imported products;
🔹 Assessment of medical device classification compliance under Circular No. 05/2022/TT-BYT;
🔹 Evaluation of quality assessment requirements for domestically manufactured medical devices;
🔹 Inspection of manufacturing, distribution, storage, transportation, traceability, and post-market records.
The MOH also requires local health authorities to coordinate closely with Market Surveillance Authorities, Customs, Police, and Steering Committee 389 to detect and address violations involving counterfeit, unregistered, unidentified-origin, or non-compliant medical devices.
Violations may be subject to administrative sanctions under Decree No. 90/2026/ND-CP, including fines, suspension of operations, product recalls, and destruction of non-compliant devices.
View more detial at: https://www.slideshare.net/slideshow/tang-c-ng-ki-m-tra-va-qu-n-ly-thi-t-b-y-t-t-i-vi-t-nam-nam-2026/288329820
📌 Key takeaway for businesses: Obtaining regulatory approval is only the beginning. Companies should maintain complete, valid, and consistent technical, regulatory, and quality documentation throughout the entire product lifecycle to ensure continued compliance during inspections and post-market reviews.
How Medgate Can Support Your Compliance Efforts
✅ Pre-audit and post-market compliance dossier review;
✅ Technical documentation gap assessment and regulatory compliance evaluation;
✅ Support for classification, applicable standards declaration, market authorization, and CFS applications;
✅ Regulatory consulting for inspections, audits, and post-market compliance activities.
Building a compliant regulatory dossier from the outset is essential to minimizing regulatory risks as post-market surveillance and compliance enforcement continue to intensify.
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