Tiếng Việt
The Ministry of Health received reports from 300 enterprises whose import licenses will expire on December 31, 2024, but need to issue circulation numbers corresponding to 3,000 applications. According to statistics, more than 1,500 applications have been issued circulation numbers.
To ensure the supply of medical devices with import licenses expiring on December 31, 2024, the Ministry of Health proposes to implement the following contents:
1. For medical devices that have an import license and have been imported into Vietnam: Circulation is allowed if it meets the provisions of Article 22, Decree No. 98/2021/ND-CP and Decree No. 07/2023/ND-CP.
2. For businesses:
- For records that have not been granted a circulation number, businesses need to review, update, and supplement documents to ensure compliance with regulations
- While waiting for the results of the circulation license for the above records, proactively place orders according to the validity of the import license to ensure the business needs of the unit
3. For medical facilities: Review and comply with legal regulations on medical device management.
According to the above official dispatch, the Ministry of Health proposes that enterprises proactively register new, review, and supplement documents for registration circulation of medical devices whose import licenses will expire on December 31, 2024, and will not renew import licenses of medical devices.
Download here:
https://medgate.vn/wp-content/uploads/2024/12/7614-CVB.pdf
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