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Manufacturing Site Inspections

Background​

Since September 2022, Russia introduced a requirement for manufacturing site QMS inspections as part of the national registration process for higher-risk devices. Following a transition period, this became fully mandatory from 1 January 2024 for new registrations and most amendments for Class IIa sterile, IIb, and III devices.

This inspection is separate from and in addition to ISO 13485 certification by a third-party certification body.

Which classes are affected​

  • Class IIa sterile — mandatory QMS inspection before submission
  • Class IIb — mandatory QMS inspection before submission
  • Class III — mandatory QMS inspection before submission
  • Class I and non-sterile Class IIa — not required

Governing regulations​

RegulationSubject
Government Decree No. 135Rules for conducting QMS inspections for medical device manufacturers
Government Decree No. 136Requirements for QMS implementation, maintenance, and assessment depending on risk class

What the inspection covers​

The inspection assesses compliance with GOST R ISO 13485 requirements at the manufacturing facility. Inspectors review:

  • Management responsibility and quality policy
  • Design and development controls
  • Production and process controls
  • Document and record control
  • Complaint handling and CAPA
  • Internal audit and management review

Remote vs on-site​

Russia has provisions for both on-site (at the manufacturing facility) and remote inspections. Given that many manufacturers are located outside Russia, remote inspection options were introduced, particularly relevant in the post-2022 geopolitical context.

Inspection outcome​

A successful inspection results in an inspection certificate that must be submitted as part of the registration dossier. The certificate has a defined validity period; if it expires during the registration review, the applicant may need to undergo a new inspection.

Timeline impact​

Plan for QMS inspection before preparing the registration submission. Scheduling, conducting, and completing an inspection typically adds 3–6 months to the registration preparation timeline.

Official sources