Inspection of medical device manufacturers

In accordance with the current legislation of the Russian Federation, manufacturers of medical devices, depending on the risk class of medical devices, are required to confirm compliance with the requirements for the implementation, maintenance and assessment of the quality management system for medical devices depending on the potential risk of their use. This requirement applies to both domestic and foreign manufacturers of medical devices in relation to those medical devices that are supplied to Russia.

In general, the quality management system for medical devices must comply with the GOST ISO 13485-2017 standard, which is harmonized with the international standard.

Inspection of production is mandatory for manufacturers of medical devices of risk classes 2b, 3 and 2a sterile.

We have prepared a presentation for you, which contains all the most relevant information: the inspection procedure, what exactly the inspectors check, who should and who can voluntarily undergo inspection, what to do if the inspection results are not perfect.