Site audits during registration of medical devices

It is no secret that in order to gain official access to the pharmaceutical market, imported and manufactured medical products must obtain a registration certificate. The regulator, according to the rules of the regulations, conducts an expert examination, which may include: documentary verification of the set of dossiers, quality control of products and production audit. However, not all of these steps are applicable to every case at the same time. There is a risk-based approach, according to which a more in-depth examination is carried out for products with a higher potential risk to users.

Inspection rules for mi registration are governed by Order KR-DSM-315/2020.

If there are almost no questions with the documentary and laboratory part, there are two main points in the inspection rules for the registration of medical devices, given the recent changes.

1. The site visit, as before, is conducted during the first examination of a product with risk class 2a (sterile), 2b and 3. However, the new order introduced the concepts of groups and subgroups. Previously, production sites entered in the state register were not subject to re-audit when new products were declared. According to the new wording, existing manufacturers from the register, when registering products belonging to new groups or subgroups, are subject to inspection of medical devices by the authorized body. Let's say a site previously registered with a sterile set of non-woven linen, and now plans to produce machinery. This manufacturer will again have a visit in the examination of MT. And the area of inspection will now be a different group of MIs.
2. There are also changes in the timeframe for the audit. Producers now have 120 days to organize the visit after signing the contract. Previously, 30 days out of 120 were used to sign the contract, pay the state duty and upload documents to the portal.

Since the above-mentioned innovations in the order significantly increase the potential costs for manufacturers, this section is discussed in detail during the initial diagnosis of each application that comes to us at the lcs-kz.

Articles on topical issues, including discussion of new versions of regulatory acts, are always available in the following section LCS Blog on our corporate website.