Batch certification is one of the main legal procedures. It can be applied for registration of imported medical devices in Ukraine.

The certificate of conformity for the batch is issued without experts going to the place of production. In fact, it is issued on the basis of a valid technical file and inspection of the lot by an auditor at customs.

Therefore, the procedure for carrying out the procedure is reduced to:

– acquaintance with the technical file;
– preparation of instructions and labeling under Ukrainian legislation;
– drawing up a contract for the customer or Authorized Representative;
– audit of the batch directly at customs;
– certificate issuance (approximately 3 – 5 days);
– customs clearance as a medical product (with a tax rate of 7%).

Obtaining a certificate of conformity for a batch of medical goods is economically feasible if the products are not imported systematically or once. As a rule, this is the supply of artificial medical electrical equipment or medical products of the same type (one model and one brand).

Would you like to learn about the possibility of batch certification of medical products?
Order a preliminary consultation from Miasphera by +38 068 498 88 58