Application and procedures for declaration of eligibility for medical device trading in Vietnam
My company is searching for the declaration of eligibility for medical device trading in Vietnam. Please provide the documents and procedures for me according to the latest regulations. Thankyou.
According to Article 41 of Decree 98/2021/ND-CP (Effective January 1, 2022), the application and procedures for declaration of eligibility for medical device trading in Vietnam are as follows:
1. An application for declaration of eligibility for medical device trading consists of:
a) The declaration of eligibility for medical device trading;
b) A personnel list;
c) Documents proving that the warehouse and vehicle satisfy the requirements specified in Clause 2 Article 40 of this Decree. These documents must be certified by the applicant;
d) Documents proving that the warehouse and inventory monitoring system for medical devices containing narcotic substances and precursors comply with the requirements laid down in Clause 3 Article 40 of this Decree. Such documents shall be certified by the establishment making declaration of eligibility for trading in medical devices that contain narcotic substances and precursors.
2. Procedures for declaration of eligibility for medical device trading:
a) Before trading medical devices, the trading establishment shall submit an application for declaration of eligibility for medical device trading to the Department of Health of province where the trading establishment is located.
b) After receiving the application (including the application fee payment as prescribed by the Ministry of Finance), the Department of Health of province where the trading establishment is headquartered shall publish on the Portal on management of medical devices all information about and application for declaration of eligibility for medical device trading.
c) During its operation, the trading establishment shall prepare a notice of changes which is accompanied by supporting documents for such changes, and update such documents to its application for declaration of eligibility for medical device trading published on the Portal on management of medical devices within 03 working days from the occurrence of such changes.
Best Regards!
