Global medical device registration service
Cosmos Biomed provides the best bridge for medical device companies to enter overseas markets. Our Asian consultant team has many years of experience in international regulations, freeing language barriers and providing online consulting services, and promptly assisting clients in obtaining evidence is our goal. No matter which country you choose to sell, we offer a complete one-stop solution to accelerate your access to the international marketplace through years of regulatory and forensic experience.
Service Portfolio
USA
FDA 510K submission (MD % IVD)
Pre market approval application
De Novo submission
FDA Pre-submission Service
FDA Listing
European Union CE mark
1. European Union Medical device MDD/ MDR CE mark consulting
2. CE technical file establishment and assessment consulting
3. The latest Quality system ISO 13485 consulting
4. Clinical evaluation report consulting (CER) / Post -market Surveillance (PMS) and Post market clinical follow up (PMCF) consulting
5. Euro Rep registration
Taiwan、Korea、India
1. Taiwan FDA Medical device registration class I/II/III and QSD application
2. Korea KFDA/ India medical device registration