The Medical Equipment devises the different category according to the risk classification of Decree 169/2018 / ND-CP:

GROUP 1: includes medical equipment of category A which is the medical equipment with a lowest risk

Regarding to group 1, the company of importing has to announce the applicable standards for class A medical equipment after classification & before importing

GROUP 2: includes medical equipment of categories B, C and D, in which:

• Category B is medical equipment with an average low risks;
• Category C is medical equipment with a medium risks;
• Category D is medical equipment with a high degree of risk.

For group 2, the company of importing need to check appendix I of Circular 30/2015 / TT-BYT: if the item belongs to Appendix I, it is required to apply for the import permit of medical equipment before importing, but NOT DEPEND, enter normally.

METHOD OF CLASSIFICATION FOR MEDICAL EQUIPMENT: 

To make classification for the medical equipment, the customer prepares the following documents:

– An application form for the classification of medical equipment

– Catalog of products (Original catalog of products in English)

– Vietnamese description of the features of the medical equipment (Form in Decree 36/2016 / ND-CP)

– ISO 9001 or ISO 13485 of the medical equipment manufacturer

– Certificate of free sale of products (issued by foreign countries)

– Certified copy of business registration

Noted: Documentation for the use of medical equipment (Vietnamese)

The general dossier is guided in the ASEAN Agreement on medical equipment (applied from January 1, 2022).