Registration of medical devices in different countries or markets. Pre-market and post-market requirements

Medical Device Post Market Surveillance in Canada

Health Canada collects post-market information from a wide variety of sources after products are approved for sale in the Canadian market, then evaluates information to come up with appropriate safety measures involving medical devices. Signal detection and assessment Health Canada continuously receives and evaluates Medical Devices Incident Reports and Post-Market Adverse Reaction Reports. Through the…

510k

510k

FDA 510k: Everything you need to know about preparing a premarket submission for medical devices A 501k is a device classification that allows manufacturers to sell their products without first obtaining approval from the FDA, but only if they meet specific criteria. That is, an FDA 510k submission is the technical documentation required by the…

Medical Device Distribution Quality Management

Medical Device Distribution Quality Management in Korea

Background Recently Korean Ministry of Food and Drug Safety (MFDS previously called KFDA) published its quality management standard for distributors operating in South Korea. Is your distributor ready ? After strengthening its regulation for license holders and require them to appoint a dedicated Quality Manager (effective since July 2014), MFDS is now regulating the distribution…

In Vitro Diagnostic

south korea medical device regulations update 2014

A notice is given for Limited Revision regarding Medical Device Act 1081; released May 9, 2014 of the South Korea medical device regulations as below: 1. Reasons for Revision A. Subcontracting B. In-Vitro Diagnostic C.License Modification exemption D.Distribution Quality Management Standard E.Periodic Reporting F. Recall Notification The pharmaceutical drugs and the medical devices are currently…

pacemaker

South Korea MFDS notice

Here is the Ministry of Food and Drug Safety Notice No. 2014-87 from South Korea. South Korea MFDS is  revising 「Regulations regarding Medical Device Products and Product Classification」 (Ministry of Food and Drug Safety Notice No. 2014-88, 2/12/2014) in part, and gathering consensus from the people. They are hereby giving a notice regarding the purpose,…