Vietnam: 03 documents served as grounds for determining the country of origin of a medical device

According to Clause 2 Article 4 of Circular No. 14/2020/TT-BYT of the Ministry of Health of Vietnam, the country of origin of a medical device is determined according to:

- The import license;

- The marketing authorization number (including the marketing authorization certificate); or

- The Certificate of Free Sale (CFS) and ISO 13485 certification.

Moreover, Circular No. 14/2020/TT-BYT also stipulates that a medical device contract may contain one or several categories of medical devices, each of which may be classified as follows:

1. Group 1: Medical devices that are both:

- Granted the CFS by at least 02 countries specified in Appendix I hereof (hereinafter referred to as “reference countries”); and

- Made in a reference country or Vietnam.

2. Group 2: Medical devices that are both:

- Granted the CFS by at least 02 reference countries; and

- Are not made in any reference country or Vietnam.

3. Group 3: Medical devices that are both:

- Granted the CFS by at least 01 reference country; and

- Made in a reference country or Vietnam.

4. Group 4: Medical devices that are both:

- Granted the CFS by at least 01 reference country; and

- Are not made in any reference country or Vietnam.

5. Group 5: Medical devices that are both:

- Granted a marketing authorization number granted in Vietnam (including those granted marketing authorization); and

- Made in Vietnam.

6. Group 6: Medical devices other than those specified above.

A bidder may apply for one or several Groups whose criteria are fully satisfied by their products, provided the bids are consistent among all Groups (classification does not apply to medical devices that are systems of multiple medical devices). To be specific:

- A bidder whose products satisfy the criteria of Group 1 may apply to Groups 1, 2, 3, 4, 5, 6;

- A bidder whose products satisfy the criteria of Group 2 may apply for Groups 2, 3, 4, 5, 6;

- A bidder whose products satisfy the criteria of Group 3 may apply for Groups 3, 4, 5, 6;

- A bidder whose products satisfy the criteria of Group 4 may apply for Groups 4, 5, 6;

- A bidder whose products satisfy the criteria of Group 5 may apply for Groups 5, 6;

- A bidder whose products do not satisfy any of the criteria of Group 1, 2, 3, 4 and 5 may only apply for Group 6.

View full text in Circular No. 14/2020/TT-BYT of the Ministry of Health of Vietnam, which takes effect from September 01, 2020.

Thu Ba

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