In what cases is a license to import medical devices required? What is the application for a license to import medical devices in Vietnam?
In what cases is a license to import medical devices required?
According to Clause 1, Article 48 of Decree No. 98/2021/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;
- Used medical devices:
+ are imported to serve research or training (no use on humans and for diagnostic and treatment purposes); or
+ are temporarily imported for re-export to serve display, product launch event, trade fair or exhibition.
In what cases is a license to import medical devices required? What is the application for a license to import medical devices in Vietnam?
What are the rules for management of import and export of medical devices in Vietnam?
According to the provisions of Article 47 of Decree No. 98/2021/ND-CP stipulating as follows:
Rules for management of import and export of medical devices
1. Importers and exporters of medical devices must satisfy eligibility requirements laid down in the law on import and export and assume responsibility to ensure quality, quantities, categories and intended purposes of their imported/exported medical devices.
2. Medical devices that have been granted registration numbers in Vietnam may be exported and imported without limits on quantities and are exempt from the Ministry of Health’s approval.
3. Issuance of Certificate of Free Sale for medical devices shall comply with regulations of the law on foreign trade management.
4. Temporary import for re-export, temporary export for re-import, or transit of medical devices shall comply with regulations of law.
5. Import of used medical devices shall comply with regulations of the law on foreign trade management.
Thus, the management of import and export of medical devices is carried out according to the above principles.
What is the application for a license to import medical devices in Vietnam?
In Clause 2, Article 48 of Decree No. 98/2021/ND-CP stipulating the application for a license to import medical devices as follows:
- The application form for import license;
- A synopsis of the technical description of the medical device in Vietnamese;
- Certificate of conformity with quality control standards of the manufacturer bearing the applicant’s certification;
- If the medical device is imported to serve research: a certified true copy of the decision to approve the research and documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;
- If the medical device is imported to serve training purposes: the original copy of the training program and documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;
- If the medical device is imported to serve testing, inspection, experiment, or performance evaluation: the certification indicating the quantity of the imported device given by the agency competent to carry out such testing, inspection, experiment, or performance evaluation;
- If the medical device is imported as aid: a copy of the decision to approve the aid and documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;
- If the medical device is imported as gift or present given to a health facility: the original copy of the training program and documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;
- If the medical device is imported to serve charitable medical examination and treatment: documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;
- If the medical device is imported to serve a health facility’s special diagnosis demand: documents bearing the applicant’s certification proving that the device has been granted marketing authorization by a competent authority;
- If the medical device is imported to serve personal treatment of illness, including personalized medical devices: a copy of the physician’s prescription which is consistent with the applicant’s illness;
- If the medical device is imported to serve a trade fair, exhibition, display or product launch event: copies of documents on the program, invitation letter and service contract;
- If the medical device is imported to serve the purposes of epidemic prevention and control or disaster recovery, the following documents are required:
+ A competent authority’s approval for import of the medical device to serve epidemic prevention and control or disaster recovery;
+ Documents bearing the applicant’s certification proving that the device has been granted marketing authorization or license for emergency use by a competent authority.
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