WHAT ARE THE CONDITIONS FOR IMPORTING MEDICAL DEVICES?

With the current situation of the Covid-19 epidemic, the demand for medical devices is a significant factor in meeting the long-term maintenance of the epidemic prevention process. Therefore, promoting the import of medical devices is prioritized to implement and strengthen in the immediate future. However, organizations and individuals who import medical devices need to meet several conditions prescribed by the law on importation. They must be responsible for ensuring the quality of the medical devices they import.

Legal basic:

Consolidation document 01/VBHN-BYT in 2020 consolidating the decree on management of medical devices issued by the Ministry of Health (“Consolidation document 01”);

Circular no. 30/2015/TT-BYT stipulating the import of medical devices;

Circular no. 42/2016/TT-BYT stipulating the recognition of results of classification of medical devices;

Circular 39/2016/TT-BYT on the classification of medical devices;

1. Classification of medical devices

Article 4 Consolidated document 01 stipulates that medical devices consist of 2 groups, which are classified into four categories based on the level of potential risks related to the technical design and manufacture of such medical devices:

• Category 1 consists of Type A medical device which are medical devices with low-risk levels.

• Category 2 consists of Types B, C, and D medical devices, in which:

- Type B medical devices consist of medical devices with low to medium risk levels;

- Type C medical devices consist of medical devices with medium to high-risk levels;

- Type D medical devices consist of medical devices with high-risk levels.

Therefore, the first step when planning to import medical devices is to carry out classification procedures, 100% of medical devices imported to Vietnam will be classified into 1 of 4 types A, B, C, D, and depending on the type, the procedures for applying for import documents will be different.

2. Conditions for importing medical devices

Article 68 of Consolidation Document 01 provided that, after classification of medical devices according to the instructions above and there is a table of classification results, depending on each type of imported medical equipment, different conditions will need to be fulfilled as follows:

• For medical equipment classified as Type A

Importation may only be made after receiving a receipt for the application for publication of applicable standards issued by the provincial, city Health Services, in addition to the customs dossier, the importing unit when importing medical devices must provide the following documents:

- The classification of medical devices according to the form specified in Appendix V issued together with the Consolidated Document 01 or papers proving the results of classification of medical devices as prescribed in Circular No. 42/2016/TT-BYT;

- Power of attorney of the owner of the circulation number (in case the importer is not the holder of the circulation number).

• For medical equipment classified into Types B, C, D on the list of medical devices promulgated together with Circular No. 30/2015/TT-BYT stipulates that the import of medical devices may only be imported when the following conditions are satisfied:

- Having an import license from the Ministry of Health according to Circular No. 30/2015/TT-BYT;

• For medical equipment classified as Types B, C, D and not on the list of medical devices promulgated together with Circular No. 30/2015/TT-BYT, when importing medical devices, the importing unit must additionally provide:

- The classification of medical devices according to the form specified in Appendix V issued together with the Consolidated Document 01; or

- Papers prove the classification results of medical devices as prescribed in Circular No. 42/2016/TT-BYT.

Currently, Decree 03/2020/ND-CP takes effect from January 1, 2020, thereby extending the license to import medical devices until December 31, 2021. Accordingly:

- For class A medical devices of the Ministry of Health that already have the certificate of declaration of applied standards issued by a Department of Health, they may be imported without limits, medical device classification forms and documents certifying that they belong to the Ministry of Health;

- Medical devices that do not require the import license and have been classified as B, C or D by a classifying organization posted on the website of the Ministry of Health may be imported until the end of December 31, 2021 without limits and documents certifying that they belong to the Ministry of Health.

ADK Vietnam Lawyers