Welcome back to The Lawyers Talk channel of BLawyers Vietnam. My name is Huynh Ngoc Uyen Chi, and nice to see everyone on today’s Podcast. Today, I will join our esteemed listeners in exploring the process of applying for a Certificate of Free Sale for type B medical devices.
Firstly, I will provide some general information about this type of Certificate before speaking about the main content of today’s topic. A Certificate of Free Sale, commonly abbreviated as CFS, is a certificate issued by a competent state authority of an exporting country to an exporter to certify that goods are allowed to circulate freely in the exporting country. The Government regulates the List of goods and CFS management authority in Appendix V of Decree No. 69/2018/ND-CP, amended by Decree No. 96/2023/ND-CP. Accordingly, medical devices are goods under the CFS-issuing authority of the Ministry of Health. Medical devices are specifically classified by enterprises into types A, B, C or D depending on the level of risk according to the classification rules specified in Appendix I of Circular No. 05/2022/TT-BYT and implementation of the Notification procedures of the Department of Health where the manufacturing facility is headquartered.
The process of applying for a CFS is strictly and complexly regulated by various legal documents, which can easily cause enterprises to miss certain aspects of the process and face difficulties in the actual implementation process. Thus, I will provide a brief and easy-to-understand system of the implementation process, application components, fees and related notes to help enterprises apply for CFS more easily. Please note that, within the scope of today’s Podcast episode, we will focus on the procedure for obtaining CFS for type B medical devices with low medium risk level – as the most common type of medical device nowadays. For medical devices classified as type A, C, or D, enterprises should review and note the different regulations and implement procedures in accordance with legal requirements.
Pursuant to current regulations, the procedures mentioned, except for the CFS application procedure at the final step, will be conducted 100% online in parallel at:
- The Public Service Portal of the Department of Health of the province or city where the production facility or business headquarters is located and
- The online public service system for medical device management (“DMEC Portal”) of the Ministry of Health.
To apply for a CFS for medical devices:
Step 1: An enterprise shall implement the procedure for announcement of eligibility for medical device production conditions.
The components of the dossier to implement the procedure for announcing production eligibility include:
- Document announcing production eligibility;
- Original or certified copy or confirmed copy of the facility requesting announcement of production eligibility for the Certificate meeting ISO 13485 quality management standards; and
- The original document confirmed by the facility proves compliance with conditions regarding the monitoring system for the process of import, export, inventory, and use of raw materials that are narcotic drugs and precursors, or contain narcotic drugs and precursors, and the conditions for safely storing the aforementioned raw materials in a separate area within the warehouse or a separate warehouse. After receiving all documents and fees, the Department of Health will conduct an inspection at the medical device manufacturing facility and publicly post the announcement dossier on the electronic portal for medical device management of the province or city where the manufacturing site is located. The fee for this procedure, according to current regulations, is VND3,000,000 per medical device.
Step 2: The enterprise shall implement the procedure for announcing the applicable standards for type B medical devices.
In fact, we have encountered a few cases where enterprises skipped this procedure because they did not see any regulations in the CFS application documentation. However, the number of the applicable standard announcement issued at this step is a mandatory requirement in the application document for the Certificate of Free Sale (CFS). The application documents will include several main types:
- The document announcing the applicable standards for medical devices of type B;
- Original or certified copy or copy certified by the organization announcing the applicable standard ISO 13485;
- The authorization letter given by the product owner to the organization that applies for declaration of applied standards, if the owner of the medical device is also the organization in whose name it is registered, replace it with an explanation document for the Department of Health with the above content;
- The certificate of eligibility to provide warranty services granted by the product owner, except in the case of disposable medical devices;
- The document describes a summary of the technical specifications of medical devices in Vietnamese, accompanied by technical documents detailing the functions and technical parameters of the medical device issued by the owner. Specifically, for reagents, calibration, and in vitro control materials, the technical documents will be accompanied by documents on raw materials, product safety, production processes, and clinical and preclinical research reports, including stability reports;
- The original or certified as true copy of the organization declaring the applicable standard of conformity certificate as per regulations or the product standard declaration by the medical device owner. Specifically, for domestically produced in vitro diagnostic medical devices, it is necessary to supplement original or certified copy of the evaluation results of chemical, physical, microbiological, and other parameters issued by a qualified facility according to the provisions of law on conformity assessment regulations or a quality assessment certificate issued by the Vietnamese competent authority;
- User manual for the medical device; and
- Label template, to be used when marketed in Vietnam, of the medical device.
When the application and fee are received, the Department of Health in the area where the medical device business is located will publicly post the announcement number of the applicable standards for type B medical devices on the electronic portal for medical device management and the applicable standards, except for the technical description documents of the medical device accompanied by technical documents describing the functions and specifications of the medical device issued by the medical device owner, and the technical documents accompanied by documents on raw materials, product safety, production processes, clinical and preclinical research reports, including stability reports for reagents, calibration substances, and in vitro control materials. The fee for this procedure for type B medical devices according to current regulations is VND3,000,000 per medical device.
Step 3: The enterprise needs to implement procedures for announcing eligibility to trade
The procedure implementation documents will include several main types:
- Document announcing eligibility to trade medical devices (Form No. 04 belongs to Appendix I of Circular No. 19/2021/TT-BYT);
- Personnel declaration (Form Appendix II of Circular No. 19/2021/TT-BYT);
- Documents proving that the storage warehouse and transportation vehicles for the medical device meet the requirements as stipulated in Clause 2, Article 40 of Decree No. 98/2021/ND-CP. These documents must be verified by the facility announcing eligibility for buy and sale; and
- Documents proving the storage warehouse and the monitoring system for the import, export, and inventory management process of medical device containing narcotic and precursors meet the requirements as prescribed in Clause 3, Article 40 of Decree No. 98/2021/ND-CP. These documents must be certified by the facility authorized to trade in medical devices containing narcotic drugs and precursors. After receiving all documents and fees, the Department of Health will conduct an inspection at the medical device trading facility where the medical device trading is located. After the assessment meets the standards, the Department of Health in the area where the medical device trading facility is located will publicly post on the electronic portal on medical device management the information and documents declaring eligibility to trade medical devices. The fee for this procedure according to current regulations is VND3,000,000 per medical device. Note that enterprises can skip this procedure in cases where medical devices are produced only for export purposes and there is no need to trade in the Vietnamese market.
Kindly note that for the payment of fees for performing procedures, fee payment will be made online at the Public Service Portal of the provincial or municipal Department of Health via QR code. Once the Department of Health has received the fee, the application at the Public Service Portal of the Department of Health and the application at the DMEC Portal will both reach the status of received.
Step 4: The enterprise will implement the procedure to apply for a CFS
The application for a CFS for medical device will include the following main documents:
- A request for a certificate of free circulation (Form No. 07, Appendix I of Circular 19/2021/TT-BYT); and
- A certified copy of ISO 13485. The enterprise can choose the number of CFSs issued for the goods. The enterprise will submit the application online at the DMEC Portal of the Ministry of Health. The fee for this procedure according to current regulations is VND1,000,000 per medical device.
The time limit for handling the above procedures is 03 working days for each procedure according to current legal regulations. However, according to BLawyers Vietnam’s experience, the time to return results may be extended in practice depending on the number of applications that the Department of Health/Ministry of Health is receiving as well as the assessment needs of experts based on each specific application.
Dear listeners, so we have gone through the regulations on implementation process, dossier components, fees as well as some notes on the necessary procedures to apply for a Certificate of Free Circulation for type B medical devices. I believe this will help our listeners have more new information as well as understand several important notes on this issue as it relates to the provisions of current law.
If you have any questions or concerns, please leave a comment below. For more information about BLawyers Vietnam, feel free to visit our website displayed below The Lawyers Talk podcast screen.
Goodbye, and see you again.
The above is not official advice from BLawyers Vietnam. If you have any questions or suggestions about the above, please contact us at info@blawyersvn.com. We would love to hear from you.
Date: 26 February 2025
