What is the latest form of the certificate of free sale for medical devices in Vietnam according to Circular 10/2023/TT-BYT?
What is the latest form of the certificate of free sale for medical devices in Vietnam?
Pursuant to Form No. 07 of Circular 10/2023/TT-BYT stipulating the form of certificate of free sale for medical devices as follows:
Download the certificate of free sale for medical devices in 2023: Click here
What is the latest form of the certificate of free sale for medical devices in Vietnam according to Circular 10/2023/TT-BYT? (Image from the Internet)
What is the application for Certificate of Free Sale for medical devices in Vietnam?
Pursuant to the provisions of Article 49 of Decree 98/2021/ND-CP stipulates as follows:
Application for Certificate of Free Sale (CFS) for medical devices
1. An application for CFS for a medical device consists of:
a) The application form for CFS.
b) A certified true copy of the unexpired certificate of conformity with quality control standards issued by a conformity assessment body as prescribed by law.
2. Procedures for the CFS shall comply with the Government’s Decree No. 69/2018/ND-CP dated May 15, 2018.
According to the above provisions, an application for CFS for a medical device consists of:
- The application form for CFS.
- A certified true copy of the unexpired certificate of conformity with quality control standards issued by a conformity assessment body as prescribed by law.
What is the procedure for granting a Certificate of Free Sale for medical devices in Vietnam?
Pursuant to the provisions of Clause 2, Article 49 of Decree 98/2021/ND-CP, as follows:
Application for Certificate of Free Sale (CFS) for medical devices
...
2. Procedures for the CFS shall comply with the Government’s Decree No. 69/2018/ND-CP dated May 15, 2018.
Referring to the provisions in Article 11 of Decree 69/2018/ND-CP stipulating as follows:
CFS for exported goods
…
2. The CFS for exported goods must be expressed in English and at least contain information prescribed in Clause 3 Article 10 hereof.
If an importing country requires the trader to submit a CFS using a form regulated by its regulations and laws, the CFS issuing authority shall issue the CFS according to such required form.
3. Procedures for issuance of CFS for exported goods
a) The trader shall send an application, in person, by post or online (if applicable) to the CFS issuing authority, including required documents below:
- An application form for CFS, stating description and HS head of the good, number of certificate of conformity with standards or registration number, standard number (if any), content of compounding materials (if any), and importing country: 1 original, expressed in Vietnamese and English.
- Investment certificate or business registration certificate, business registration certificate: 1 copy bearing the trader's stamp.
- List of manufacturing facilities (if any), including name and address of facilities, products manufactured for export: 1 original.
- A document of applied standards for the good enclosed with display (on label or packages or packaging manual thereto): 1 copy bearing the trader's stamp.
b) If the required documents are incomplete or invalid, the CFS issuing authority shall, within 3 working days from the date on which the application is received, notify the trader of deficiencies and allow the trader to correct the deficiencies.
c) If the required documents are complete and valid, the issuing authority shall issue the CFS within 3 working days from the receipt date. If the application is rejected, the CFS issuing authority shall provide explanation in writing.
d) The CFS issuing authority may undertake a verification visit to the facility if the verification of application gives insubstantial grounds for issuing a CFS or any breach of regulations associated with the former CFS is found.
dd) The trader may request number of CFS to be issued.
e) If the trader wishes to amend the CFS or have the CFS which is lost replaced, it shall send an application for amendment or replacement and required documents to the CFS issuing authority. Within 3 working days from the date on which a complete and valid application is received, the CFS issuing authority shall consider amending the CFS or grant a duplicate to the trader.
4. The Ministry or ministerial-level agency shall revoke the CFS if:
a) The exporter falsifies the documentary evidence or documents; or
b) CFS is issued for goods that are not conformable to applied standards.
Accordingly, the procedure for granting a Certificate of Free Sale for medical device is carried out in accordance with the above regulations.
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