We appreciate your interest in Freyr’s webinar series. Our recent session on ‘Label the Labeling Data to organize, regulate, simplify, uncomplicate – EU,’ has successfully been concluded.
We appreciate your interest in Freyr’s webinar - “Clinical Evaluation Report (CER) - Decode the Step-wise Approach for Compliance.” We are happy to announce that the session was successfully completed on December 11, 2018.
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Netherlands is one of the major medical device markets in Europe accounting to 3-4 % of market share. The Health Care Inspectorate (Inspectie voor Gezondheidszorg or IGZ) of Dutch Ministry of Health is responsible for implementing the Dutch Medical Devices Act in Netherlands. To market the medical devices in Netherlands, manufacturers are required to perform a CE certification conformity assessment, prepare a technical file, and draw up the conformity declaration. In addition, they must apply for the CE marking for the product, as per the EU rules and regulations.
With its universal healthcare system, Germany offers a good deal of business opportunities for medicines / medical device manufacturers. The Federal Institute for Drugs and Medical Devices, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) oversees / regulates respective Regulatory activities in the region. With the world’s oldest healthcare system and with many reforms followed by, the Regulatory regime in Germany stands one of the toughest to deal with while approaching for necessary registrations and approvals.
United Kingdom (UK), has one of the world’s best healthcare policies, thus attracting renowned pharmaceutical players from across the globe. Medicinal products must be marketed in the country only after registering the product and obtaining an approval from Medicines and Healthcare Products Regulatory Agency (MHRA). As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:
Sweden is a prominent player for Pharmaceuticals market. With increasing healthcare expenditures, the market projections are lucrative. The country’s regulations mandate that a medicinal product must be approved by the Medicinal Products Agency of Sweden before marketing for human consumption. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:
The Spanish pharmaceutical market, despite its modest outset, predicts a consistent demand for medicinal products. Any drug or biological product to be marketed in Spain must be approved by the Spanish Agency of Medicines and Medical Devices (AEMPS). As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:
Poland has the largest Pharmaceutical market in Central and Eastern Europe and a structured healthcare system boasting good market opportunities for aspiring medicinal product manufacturers. For compliant market access, manufacturers must register their medicinal products with Chief Pharmaceutical Inspectorate of Poland. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:
Netherlands has a modern healthcare system in place that keeps the demand for Pharmaceuticals consistent. To be successfully marketed in the country, manufacturers and distributors must obtain an approval from Healthcare Inspectorate of Netherlands. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:
Italy is a prominent EU nation with steady demand for drug and biological products. Italian Medicines Agency is responsible to grant approval for the medicinal products before they are marketed in the country which can be obtained by submitting a Marketing Authorization Application (MAA). As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures: