Until when is the validity of marketing authorization numbers of medical devices in Vietnam extended? Until when is the validity of the license to import medical devices in Vietnam extended?
Until when is the validity of the license to import medical devices in Vietnam extended?
Pursuant to Clause 18, Article 1 of Decree No. 07/2023/ND-CP stipulating the extension of the validity of the license to import medical devices as follows:
- An import license for medical devices other than IVD reagents which is issued within the period from January 01, 2018 to December 31, 2021 shall remain valid until December 31, 2024 inclusively;
(Compared to point c, clause 2, Article 76 of Decree No. 98/2021/ND-CP, import licenses issued to medical devices other than IVD reagents on January 01, 2018 onwards shall be valid until December 31, 2022 inclusively).
- An import license for medical devices which are IVD reagents which is issued within the period from January 01, 2018 to December 31, 2021 shall remain valid until December 31, 2024 inclusively and impose no limit on import quantities;
(Compared to Point dd Clause 2 Article 76 of Decree No. 98/2021/ND-CP, medical devices that are IVD reagents and have been granted registration number within the period from January 01, 2014 to December 31, 2017, these registration numbers shall be valid until December 31, 2022).
- The import of medical devices which are not subject to import license requirements (except insecticidal and germicidal chemicals and preparations for medical and household use which are used for disinfection of medical devices only) and have been classified as Class-C or D medical devices as published on the web portal of the Ministry of Health of Vietnam may continue until the end of December 31, 2024 without limits on import quantities and requiring the Ministry of Health of Vietnam’s confirmation as medical devices, regardless of the time of publishing information on such medical devices on the web portal of the Ministry of Health of Vietnam.
(Compared with Point d, Clause 2, Article 76 of Decree No. 98/2021/ND-CP, Medical devices which are not subject to import license requirements (except insecticidal and germicidal chemicals and preparations for medical and household use which are used for disinfection of medical devices) and have been classified as Class-C or D medical devices as published on the Ministry of Health’s Portal may continue to be imported until December 31, 2022 without limits on quantities and confirmation as medical devices from the Ministry of Health of Vietnam).
Thus, Decree No. 07/2023/ND-CP has extended the validity of the license to import medical devices according to the above regulations.
Until when is the validity of marketing authorization numbers of medical devices in Vietnam extended? Until when is the validity of the license to import medical devices in Vietnam extended?
Until when is the validity of marketing authorization numbers of medical devices in Vietnam extended?
Pursuant to Clause 18, Article 1 of Decree No. 07/2023/ND-CP stipulating the extension of marketing authorization numbers of medical devices as follows:
- Registration numbers issued according to the Decree No. 36/2016/ND-CP before January 01, 2022 shall remain valid indefinitely;
- Certificates of registration of domestically manufactured medical devices issued before January 01, 2022 shall remain valid until the expiry dates thereon;
- Marketing authorization numbers of medical devices which are IVD reagents issued within the period from January 01, 2014 to December 31, 2019 shall remain valid until December 31, 2024 inclusively;
- Marketing authorization number issued to medical devices that are IVD reagents within the period from January 01, 2020 to December 31, 2021 shall remain valid until the expiry dates on issued marketing authorization certifications;
Compared with Clause 3, Article 76 of Decree No. 98/2021/ND-CP and Clause 4, Article 76 of Decree No. 98/2021/ND-CP, the validity period of the marketing authorization numbers of medical devices is as follows:
Transition
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3. Applications for registration number which are submitted in accordance with the Decree No. 36/2016/ND-CP before January 01, 2022 but have been not yet processed before the effective date of this Decree shall be processed as follows:
a) With regard to an application for registration of Class-B medical device, the Ministry of Health shall instruct the applicant to review the application and follow procedures for declaration of applied standards in accordance with this Decree without paying application fee.
b) With regard to an application for registration of Class-C or D medical device, the Ministry of Health shall issue registration number according to Article 32 of this Decree if it meets the requirements laid down in Clause 3 Article 30 of this Decree;
c) Classification result given by the classification body that has been granted certification of declaration of eligibility to classify medical devices before the effective date of this Decree may be used.
4. Applications for license to import medical devices submitted before January 01, 2022 shall be processed in accordance with legislative documents promulgated by the Minister of Health before the effective date of this Decree. An import license issued according to the provisions of this Clause shall be valid until December 31, 2022.
Thus, compared with Decree No. 98/2021/ND-CP, Decree No. 07/2023/ND-CP has extended the validity of marketing authorization numbers of medical devices.
In which cases is an import license required?
Pursuant to the provisions of Clause 1, Article 48 of Decree No. 98/2021/ND-CP (amended by Clause 12, Article 1 of Decree No. 07/2023/ND-CP), an import license is required in the following cases:
- Unregistered medical devices are imported to serve scientific research, testing, inspection, experiment, performance evaluation, or instruction for use or device modification only;
- Unregistered medical devices are imported to serve epidemic prevention and control, or disaster recovery;
- Unregistered medical devices are imported as assistance or humanitarian aid; gifts or presents given to health facilities; or to serve display at trade fair, exhibition or product launch event;
- Unregistered medical devices are imported to serve charitable medical examination and treatment;
- Unregistered medical devices are imported for personal treatment of illness, including personalized medical devices, or to serve a health facility’s special diagnosis demand;
- Unregistered medical devices are imported for use in health facilities with ODA funding and concessional loans or grants other than ODA grants.
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