Applications for licenses to import medical devices in Vietnam
My company is about to import some medical devices, and as I understand, import permits are required in Vietnam. What does the applications for licenses to import medical devices in Vietnam comprise? Looking forward to support under the new regulations.
According to Clause 2, Article 48 of Decree 98/2021/ND-CP (Effective from 01/01/2022), regulations on applications for licenses to import medical devices in Vietnam include:
2. An application for the import license consists of:
a) The application form for import license;
b) A synopsis of the technical description of the medical device in Vietnamese;
c) Certificate of conformity with quality control standards of the manufacturer bearing the applicant’s certification;
d) 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;
dd) 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;
e) 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;
g) 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;
h) 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;
i) 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;
k) 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;
l) 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;
m) 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;
n) 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.
Best Regards!
