Registration of medical devices in different countries or markets. Pre-market and post-market requirements
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…
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…
PreMarket Medical Devices in Canada Applicants, may it be the manufacturer, importer, or distributor must obtain a license before their product is released to the Canadian market (PreMarket Medical Devices in Canada essential step). This is true for all types of products, may it be drugs, foods, cosmetics, and even medical devices. Products which fall…
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…
A public consultation was published regarding the South Korea medical device regulations as below (Ministry of Food and Drug Safety Notice No. 2014-88 as of April 18, 2014) original notice is here: 1. Reasons for Revision A. Exempting license/notification of medical device for emergency such as life-threatening situations B. Clarifying the range of restriction…
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…
May 16, 2014: the list of harmonized standards for the medical devices directive is updated. It’s been more than one year since this list was updated. Last time was Jan. 24, 2014. So what’s the change ? Since it is very hard to figure out just by reading the publication on the Official Journal of…
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,…
As per Notice from MFDS: The Heart Rate Monitor and Pulse Monitor that are used for exercise and leisure purpose need not be included in the product classification for the medical purpose. In defining the Heart Rate Monitor and Pulse Monitor, those that are designed for exercise and leisure will be excluded (Appendix A26080.01, A26080.02).…