What does the application for issuing a certificate of free sale for exported medical devices in Vietnam include?
- What does the application for issuing a certificate of free sale for exported medical devices in Vietnam include?
- What are the procedures for issuing a certificate of free sale for exported medical devices in Vietnam?
- Which agency has the power to issue certificates of free sale for medical devices in Vietnam?
- In what cases will the Ministry of Health issue a certificate of free sale for medical devices in Vietnam?
What does the application for issuing a certificate of free sale for exported medical devices in Vietnam include?
Pursuant to Article 49 of Decree 98/2021/ND-CP stipulating 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.
Thus, persons wishing to be issued certificates of free sale for exported medical devices in Vietnam must the application including the following documents:
- 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 are the procedures for issuing a certificate of free sale for exported medical devices in Vietnam?
Pursuant to Clause 2, Article 49 of Decree 98/2021/ND-CP stipulating 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.
According to Clause 3, Article 11 of Decree 69/2018/ND-CP, the procedures for issuing a certificate of free sale for exported medical devices are as follows:
- Step 1: The trader shall send an application, in person, by post or online (if applicable) to the CFS issuing authority
- Step 2: 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.
- Step 3: 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 an explanation in writing.
Note:
- 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.
- The trader may request a number of CFS to be issued.
- 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.
Which agency has the power to issue certificates of free sale for medical devices in Vietnam?
Pursuant to Article 50 of Decree 98/2021/ND-CP stipulating as follows:
Authority and procedures for issuance, re-issuance and revocation of CFS
1. The Minister of Health shall consider issuing, re-issuing and revoking CFS for medical devices.
2. Procedures for issuance, re-issuance and revocation of CFS shall comply with the Prime Minister’s regulations on issuance of CFS.
Thus, the Minister of Health shall consider issuing CFS for medical devices in Vietnam.
In what cases will the Ministry of Health issue a certificate of free sale for medical devices in Vietnam?
Pursuant to Clause 1, Article 11 of Decree 69/2018/ND-CP stipulating as follows:
CFS for exported goods
Ministries and ministerial-level agencies empowered to issue CFS for exported goods shall issue a CFS when:
a) Receiving an application for CFS submitted by an exporter; and
b) Considering that goods have applied standards as per the regulations and laws in force.
Thus, the Ministry of Health issue a certificate of free sale for medical devices in Vietnam when:
- Receiving an application for CFS submitted by an exporter; and
- Considering that goods have applied standards as per the regulations and laws in force.
LawNet
