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The Decree of the Government of the Russian Federation 135 strictly regulates the organization and inspection of production of medical products in accordance with the requirements for implementation, Maintain and evaluate the quality management system of medical products based on their potential risk.
Main types of inspections:
Main types of inspections:
Accompanying the inspection of PP 135 RF
Назад
Unscheduled inspection - is carried out in the event of certain circumstances, such as receiving information about non-conformity of products or production, withdrawal of products, changes in the production process
Periodic (scheduled) inspection - conducted at a certain frequency (usually every 5 years) for enterprises included in the register
Primary inspection - before registering a medical device or making changes to the registration file
Follow-up stages of medical product inspection
We guarantee support and assistance in all aspects of the inspection: documentation, equipment, premises, personnel, production process and CMC
The first step is a thorough evaluation of the existing quality management system (QMS) in the enterprise. It includes:
• Analysis of compliance with ISO 13485.
• Assessment of the readiness of documents and procedures.
• Preparation plan for inspection.
Documents to be verified:
• Employee certification for special processes.
• Third party contracts.
• Ventilation maintenance.
• Ownership of the object.
• Checking the correctness of special processes (gluing, cleaning, sterilization, soldering, welding, packaging).
• Critical suppliers.
• Details of RnD documents.
• SOP list (Reference).
• Key performance indicators for each process.
• Quality report.
• Documents of the entire quality management system.
• Analysis of compliance with ISO 13485.
• Assessment of the readiness of documents and procedures.
• Preparation plan for inspection.
Documents to be verified:
• Employee certification for special processes.
• Third party contracts.
• Ventilation maintenance.
• Ownership of the object.
• Checking the correctness of special processes (gluing, cleaning, sterilization, soldering, welding, packaging).
• Critical suppliers.
• Details of RnD documents.
• SOP list (Reference).
• Key performance indicators for each process.
• Quality report.
• Documents of the entire quality management system.
Preliminary assessment and preparation of documents
01
Preparation and submission of an inspection request, which shall include:
• All medical products (MD) that are being manufactured, are in the process of registration or are scheduled for registration within the next 5 years.
• Names of MI without the need to indicate their composition, division into groups.
• Preparation of the complete package in Russian and, if necessary, in English.
• All medical products (MD) that are being manufactured, are in the process of registration or are scheduled for registration within the next 5 years.
• Names of MI without the need to indicate their composition, division into groups.
• Preparation of the complete package in Russian and, if necessary, in English.
Preparation of inspection application
02
During the inspection preparation phase, all necessary documents are translated and then certified:
• Translation of all M&E documents and additional documents at the discretion of the inspection.
• Certification of part of the documents before the actual visit to the production and remaining documents after the inspection visit.
• Translation of all M&E documents and additional documents at the discretion of the inspection.
• Certification of part of the documents before the actual visit to the production and remaining documents after the inspection visit.
Translation and certification of documents
03
The inspection is conducted over 3 days and includes:
• Verification of the main production processes: design and development, production control (procedures for checking raw materials), interaction with the consumer (notification to Russia).
• Fixing of discrepancies with the classification by the scoring system (from 1 to 6 points).
• Preparation of the interim report on the results of the audit.
• Verification of the main production processes: design and development, production control (procedures for checking raw materials), interaction with the consumer (notification to Russia).
• Fixing of discrepancies with the classification by the scoring system (from 1 to 6 points).
• Preparation of the interim report on the results of the audit.
Inspection
04
After the inspection, the manufacturer has 30 working days to correct the discrepancies:
• Development and implementation of corrective and preventive actions.
• Preparation of photo and video materials with confirmation of the elimination of inconsistencies.
• Collect and submit additional information for the final report.
• Development and implementation of corrective and preventive actions.
• Preparation of photo and video materials with confirmation of the elimination of inconsistencies.
• Collect and submit additional information for the final report.
Reconciliation of discrepancies
05
The final stage includes receiving a final report on the inspection and submitting it to the Ministry of Health of the RF:
• The final report is attached to the registration file.
• The inspection protocol is valid for 5 years, which allows avoiding repeated inspections during this period.
• The final report is attached to the registration file.
• The inspection protocol is valid for 5 years, which allows avoiding repeated inspections during this period.
Receipt of final report and registration
06
The inspection takes about 50-60 working days (2.5-3 months) from the time of application to the inspection.
Approximate time frame for the procedure
07
Other services in the framework of CMC consulting
RZN Expert provides services for QMS analysis and implementation in compliance with ISO 13485 requirements for medical devices. We conduct an in-depth assessment of your processes, identify vulnerabilities, and develop tailored solutions for improvement.
Our experts will help you not only obtain ISO 13485 certification but also implement safe and effective procedures that meet global standards. We ensure full compliance with all medical device quality management system requirements, opening new opportunities for international market entry and increasing trust in your products.
RZN Expert also offers a full range of services for medical device registration with Roszdravnadzor.
Our experts will help you not only obtain ISO 13485 certification but also implement safe and effective procedures that meet global standards. We ensure full compliance with all medical device quality management system requirements, opening new opportunities for international market entry and increasing trust in your products.
RZN Expert also offers a full range of services for medical device registration with Roszdravnadzor.
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