Medical Devices

Certificate of Free Sale (CFS) for Class C and D Medical Devices

In the context of increasing global integration, the Certificate of Free Sale (CFS) is one of the key requirements for enterprises to export medical devices to international markets. For Class C and D medical devices – which are considered medium-high and high-risk – obtaining a CFS not only ensures compliance with Vietnamese regulations but also strengthens credibility and competitiveness abroad.

1. CFS application process

  • Step 1: Submit the application online via the Ministry of Health’s Public Service Portal (https://dichvucong.moh.gov.vn) or the Medical Device Management Portal (https://imda.moh.gov.vn). 
  • Step 2: Within 3 working days, if the application is incomplete, the Department of Infrastructure and Medical Devices will request amendments. 
  • Step 3: If valid, the CFS will be issued within 3 working days. In case of rejection, the Ministry of Health will provide written reasons.
     Site inspections may be conducted if documentation is insufficient or non-compliance is suspected. 

2. Required documents

  • Application for issuance of CFS (Form No. 07, Circular 19/2021/TT-BYT). 
  • Certificate of Quality Compliance issued by an accredited conformity assessment body, valid throughout the registration process. 

Documents must be submitted in originals or certified copies.

3. Processing time and fee

  • Processing time: 3 working days from receipt of valid dossier. 
  • Fee: VND 1,000,000 per application (as regulated under Circular 59/2023/TT-BTC). 
  • Unlimited copies of CFS may be issued upon request.

Medgate offers a variety of medical device services to help customers optimize costs and avoid wasting time searching for reputable and professional service providers

4. Applicable entities and authority

Enterprises, foreign-invested companies, organizations, cooperatives, and foreign entities exporting Class C and D medical devices.
 The competent authority: Department of Infrastructure and Medical Devices – Ministry of Health.

5. Legal basis

  • Decree No. 98/2021/ND-CP and its amendments (07/2023/ND-CP, 96/2023/ND-CP, 148/2025/ND-CP). 
  • Circulars 19/2021/TT-BYT and 10/2023/TT-BYT. 
  • Circular 59/2023/TT-BTC on medical sector fees and charges. 

6. Importance of CFS for enterprises

A CFS provides:

  • International recognition of product quality. 
  • Competitive advantage in bidding and contracting. 
  • Market expansion, particularly in countries requiring CFS for imports. 

MEDGATE – a leading consultancy in medical device registration in Vietnam – supports enterprises with professional services to shorten processing time, minimize risks, and focus on core business activities.

📞 For consultation on medical device registration, licensing procedures, and quotation, please contact:

  • Hotline: +84 98 546 1894
  • Email: medgatevn@gmail.com