Application for the import license of medical devices in Vietnam

Application for the import license of medical devices in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. Cases required import license of medical devices in Vietnam

According to Clause 1, Article 48 of Decree 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.

Procedures for import, temporary import for re-export of medical devices shall comply with regulations of the law on foreign trade management.

2. Application for the import license of medical devices in Vietnam

Specifically, in Clause 2, Article 48 of Decree 98/2021/ND-CP, an application for the import license in Vietnam consists of:

- 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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