RFLSP project presents detailed guide for international certification of medical products and devices - Russian-Finnish Life Science Park | Российско-Финский парк живых систем

Access to the global markets for manufacturers of pharmaceutical substances and in vitro diagnostic tests becomes faster, clearer and easier with the help of step-by-step instructions prepared in the framework of “Russian-Finnish Life Science Park” – large infrastructure project of the South-East Finland-Russia Cross-border cooperation Programme.

Guide For Medicinal Products and In Vitro Diagnostic (IVD) Medical Devices describes in detail regulatory framework, product requirements, necessary preclinical and clinical studies, and other steps required to obtain licenses to sell these products in Finland and EU.

A key feature of the publication is the visualization of instructions, which makes the information easier to understand. An important part of the directory is links to certification centers, consulting centers and government agencies, where you can get additional information and project support.

Internationalization of small and medium-sized enterprises in Russia and Finland is an important part of the Russian-Finnish Life Science Park project. In addition to information support for Russian manufacturers of pharmaceutical substances and diagnostic tests, numerous events are planned: international business missions, participation in key industry exhibitions, exchange of experience with Finnish universities and companies, as well as an international acceleration program.

Report contents

PART I: MEDICINAL PRODUCTS

1. BASICS OF MEDICINAL PRODUCTS
2. GOOD PRACTICES (GXP)
3. PHARMACEUTICAL DEVELOPMENT
4. PRE-CLINICAL DEVELOPMENT
5. CLINICAL DEVELOPMENT
6. MARKETING AUTHORISATION APPLICATIONS
7. MAINTENANCE OF MARKETING AUTHORISATION
8. MARKET ACCESS AND MAINTAINING A MEDICINAL PRODUCT ON THE MARKET
9. SCIENTIFIC ADVICE

PART II: IN VITRO DIAGNOSTIC (IVD) MEDICAL DEVICES

1. BASICS OF IN VITRO DIAGNOSTIC (IVD) MEDICAL DEVICES
2. DEFINITIONS
3. LEGISLATION AND TRANSITION PERIOD BETWEEN THE OLD DIRECTIVE AND THE NEW REGULATION
4. CLASSIFICATION
5. CONFORMANCE CRITERIA
6. CONFORMITY ASSESSMENT ROUTES
7. CE MARKING AND DECLARATION OF CONFORMITY 
9. PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE, PRRC
10. AUTHORISED REPRESENTATIVE
11. REGISTRATION OF DEVICE
12. SUMMARY OF SAFETY AND PERFORMANCE
13. EUDAMED

Interested in details? Download the report now!

Available downloads:

The project is funded by the European Union, the Russian Federation and the Republic of Finland in the framework of South-East Finland-Russia CBC 2014-2020 Programme. The project is executed by Saint Petersburg Technopark (RUS) (Lead partner) and Municipality of the city of Kotka (FIN).

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