Regulations on application for the import license for medical device in Vietnam

Regulations on application for the import license for medical device in Vietnam
Trần Thanh Rin

What are the regulations on application for the import license for medical device in Vietnam? – My Phuong (Quang Ngai)

Regulations on application for the import license for medical device in Vietnam

Regulations on application for the import license for medical device in Vietnam (Internet image)

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

1. What is medical device?

According to Clause 1, Article 2 of Decree 98/2021/ND-CP, medical device means any instrument, implant, apparatus, material, in-vitro reagent or calibrator, or software that meets all of the following requirements:

(i) It is intended, by the product owner, to be used, whether alone or in combination, for human beings for the purpose of one or more of the following:

- Diagnosis, prevention, monitoring, treatment or alleviation of disease, or compensation for an injury or trauma;

- Investigation, replacement, modification or support of the anatomy or of a physiological process;

- Supporting or sustaining life;

- Control of conception,

- Disinfection of medical devices;

- Providing information serving diagnosis, monitoring or treatment through examination of specimens derived from the human body.

(ii) The device does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means to serve the purposes mentioned in (i).

2. Regulations on application for the import license for medical device in Vietnam

An application for the import license for medical device consists of:

(1) The application form for import license for medical device;

(2) A synopsis of the technical description of the medical device in Vietnamese;

(3) Certificate of conformity with quality control standards of the manufacturer bearing the applicant’s certification;

(4) 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;

(5) 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;

(6) 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;

(7) 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;

(8) 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;

(9) 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;

(10) 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;

(11) 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;

(12) 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;

(13) 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.

(14) In the case specified in Point e Clause 1 of this Article, the application for import license for medical device shall include:

- The original copies or certified true copies of the decision to approve the investment guidelines and the investment decision for an investment project or the decision to approve project documents for a project on technical assistance, project costs or grants other than ODA grants, in which the import of medical devices must be indicated;

- The original copy of certified true copy of the contract for supply of medical devices for the project;

- The power of attorney granted by the product owner to the applicant which must be still valid at the date of application submission. Either the document bearing consular legalization or the certified true copy thereof is accepted;

- The certificate of eligibility to provide warranty services granted by the product owner, except disposable medical devices defined by product owners or cases where there are documents proving that the medical device is not under warranty. Either the document bearing consular legalization or the certified true copy thereof is accepted;

- The unexpired CFS (for imported medical devices). Either the document bearing consular legalization or the certified true copy thereof is accepted. If the CFS is made neither in English nor in Vietnamese, it shall be translated into Vietnamese. The Vietnamese translation must be certified as prescribed by law.

(Clause 2, Article 48 of Decree 98/2021/ND-CP (amended in Clause 12, Article 1 of Decree 07/2023/ND-CP))

3. What are the cases required an import license for medical device in Vietnam? 

Specifically, in Clause 1, Article 48 of Decree 98/2021/ND-CP, an import license for medical device 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.

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