Rajkiran Kolakota*, D. Usharani
Department of Pharmaceutical Regulatory Affairs, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, A.P
A B S T R A C T
The purpose of this study is to illuminate the importance of medical devices, regulatory requirements for the registration of medical device manufacturers in U.K. The controversy for companies developing and producing medical device is to update on the regulatory requirement and implement them in the process. Medicines and devices are regulated under European Union (EU) law, the regulatory regimens are very different, and some have argued that features of the pharmaceutical regime should be applied to medical devices in the current review of the medical device directives. The UK medical device market is third largest in Europe; the medical device trade is import-led, as most domestically manufactured products are exported to other markets. But two of these countries had different regulations to maintain the quality of medical devices marketing in their countries. The review will give a brief statement of the main points of regulatory requirements and registration of medical devices.
Keywords: Medical device, Regulations, Registrations, Approval.