Request for service
Request a call
Application for medical device development service
Application for Medical Device QMS Service
Application for medical device registration service
Application for registration of medicines
Request for service of amendments to RC/RD
Request for marketing research service for MD and Pharmaceuticals
Application for technical and medical translation
Service for compliance with the requirements of the Order of the Ministry of Health of the Russian Federation No. 1113n
Назад
We offer comprehensive services to accompany manufacturers and suppliers of medical products in order to comply with the Ordinance of the Ministry of Health of the Russian Federation 1113, which establishes the procedure for reporting adverse events in the application and operation of medical products.
Our goal is to help you organize and successfully pass the process of reporting all adverse events, minimize risks and ensure full compliance with legislation.
Service steps in adverse event reporting order
- Analysis of medical products and their accompanying documentation to assess compliance with the requirements of the Order.
- Evaluation of procedures within the company to identify side actions and their accounting.
- Evaluation of procedures within the company to identify side actions and their accounting.
Product analysis for compliance with the requirements of Order 1113n
01
- Advice on the collection and preparation of information about cases of adverse events, undesirable reactions or characteristics of interaction of medical products.
- Development and submission of documents necessary for reporting of detected cases in the Roszdravnosti (PRZ)
- Development and submission of documents necessary for reporting of detected cases in the Roszdravnosti (PRZ)
Advice and preparation for reporting
02
- Reporting of adverse events and corrective actions on the safety of medical products.
- Advice on correct filling in and reporting to electronic systems of PRZh through GIS or Unified State Services Portal.
- Advice on correct filling in and reporting to electronic systems of PRZh through GIS or Unified State Services Portal.
Preparation of communications and documents for submission to the Russian Federation
03
- Support in the process of interaction with PRN, including receipt of acknowledgments of registration of messages.
- Follow-up of contacts with medical organizations to collect data on adverse events and their analysis.
- Advice on possible corrective actions to address identified issues.
- Follow-up of contacts with medical organizations to collect data on adverse events and their analysis.
- Advice on possible corrective actions to address identified issues.
Support for interaction with government bodies
04
- Assistance in the organization of clinical monitoring of safety and efficacy for medical products 3 risk class.
- Preparation and submission of annual monitoring reports in accordance with the requirements of the legislation.
- Advice on monitoring, corrective action and reporting processes.
- Preparation and submission of annual monitoring reports in accordance with the requirements of the legislation.
- Advice on monitoring, corrective action and reporting processes.
Clinical monitoring and reporting
05
- Instructing and training client staff on the processes of detection and reporting of adverse events.
- Preparation for possible audits by the PRN and other government bodies.
- Advice on changes to documentation and process of work in case of updating the requirements of legislation.
- Preparation for possible audits by the PRN and other government bodies.
- Advice on changes to documentation and process of work in case of updating the requirements of legislation.
Briefing and follow-up
06
Benefits of using the services of RZN.Expert specialists
Result - your medical products will meet the requirements of Russian legislation, which will allow to successfully promote and use them in the market with minimal risks.
• Reducing risks by complying with legal requirements.
• Full support at every stage, from analysis to interaction with public authorities.
• Ensuring prompt and correct reporting of adverse events, which increases product safety in the market.
Other services under MI registration
m. Kropotkinskaya
Moscow, Voekhonka Street, 15
Our Medtech Business information resource on telegram. Legislative changes, market overview and science in the field of medical devices.
