Medical Devices

Instructions for the Procedure to Continue Circulating Class C and D Medical Devices in Cases Where the Owner Ceases Production, Declares Bankruptcy, or is Dissolved

In the field of medical devices, ensuring continuity in circulation and maintenance is a critical factor, especially in situations where the device owner ceases production, declares bankruptcy, or is dissolved. To address this issue, safeguard user rights, and ensure healthcare safety, the Ministry of Health has established a special procedure that allows the continued circulation of Class C and D medical devices in such cases.

This article provides detailed information on the process, conditions, and required documentation for enterprises, organizations, and individuals to comply with current legal regulations.

Scope and Applicability

This procedure applies to Class C and D medical devices that have already been granted a marketing authorization number but are subject to the following circumstances:

  • The owner of the medical device declares discontinuation of production; or

  • The owner of the medical device is declared bankrupt or is dissolved.

Entities eligible to carry out the procedure include: domestic enterprises, foreign-invested enterprises, foreign organizations, and cooperatives with rights to distribute and provide warranty services for medical devices in Vietnam.

Procedure Steps

Step 1: Within a maximum of 60 days from the date the device owner declares discontinuation of production, bankruptcy, or dissolution, the marketing authorization holder or the distributor must submit a commitment dossier to the Ministry of Health.

Step 2: Within 15 working days from the date of receipt of a complete and valid dossier, the Ministry of Health will issue a written approval or rejection for the continued circulation of the device. If rejected, the regulatory authority must clearly state the reasons.

Step 3: If not approved, the marketing authorization holder or distributor must recall all devices currently circulating in the market, except those already sold to end users.

Required Documentation

  1. Application letter requesting continued circulation of the medical device, accompanied by a commitment to provide warranty, maintenance, and replacement parts throughout the device’s usage period (Form No. 01, Appendix X – Circular No. 19/2021/TT-BYT).

  2. List of medical devices with valid marketing authorization numbers that are in stock but whose owner has declared discontinuation of production or dissolution.

Submission method: Online via the Ministry of Health’s portal: http://imda.moh.gov.vn

Important Conditions to Note

  • Extended circulation period: Maximum of 24 months from the date the device owner declares discontinuation of production, bankruptcy, or dissolution.

  • Mandatory commitment: During the extended circulation period, the applicant must ensure warranty, maintenance, and the supply of consumables or spare parts for 8 years from the date of dossier submission.

  • Non-applicability: These provisions do not apply in cases where the marketing authorization holder is a representative office of a foreign trader in Vietnam.

Processing Time and Competent Authority

  • Processing time: 15 working days from the receipt of a complete and valid dossier.

  • Competent authority: Department of Infrastructure and Medical Equipment – Ministry of Health.

Legal Basis

  • Decree No. 98/2021/NĐ-CP dated November 8, 2021, on the management of medical devices.

  • Circular No. 19/2021/TT-BYT dated November 16, 2021, detailing the circulation of medical devices.

  • Decrees No. 07/2023/NĐ-CP, No. 96/2023/NĐ-CP, No. 42/2025/NĐ-CP, and No. 148/2025/NĐ-CP on functions, tasks, and decentralization within the health sector.

The procedure for continuing the circulation of medical devices in cases of production cessation, bankruptcy, or dissolution is a flexible mechanism designed to maintain market stability and ensure user safety. Distributors and relevant organizations should proactively monitor the manufacturer’s status and strictly comply with the regulatory steps to legally continue their business operations.

Understanding the process and staying updated with legal requirements not only ensures sustainable business operations but also contributes to improving the quality of healthcare services for the community.

For consultation on medical device registration, functional foods, cosmetics, and dietary supplements in compliance with current regulations, please contact us at Hotline: 098.546.1894.