Staying up to date requires a lot of time and effort when you are working in the medical devices industry. You need first to select the proper source of information then filter to match with your product category. Finally you only can guess which standard could be appropriate. Medical Standards List is a new service…
It’s not only a name change in fact. Of course the Korean FDA became The MFDS (Ministry of Food and Drug Safety), but beyond that the agency has been promoted to a ministry level.
Technical document review A technical document review is a general “technical document review” (TDR) for those products that are basically the same as an already approved product, whereas a “safety and efficacy review” (SER) is required for devices unlike those currently available on the market – falling under new structure, new performance, new intended use,…
Starting here is a serie of posts related to Korean Regulation, the first one being about South Korea KGMP inspection requirements which is equivalent of the US Good Manufacturing Practice. Quality system regulations (KGMP) All Medical Devices are required to be manufactured under GMP. Premarket GMP audit is mandatory for all class II, III…
Update on the above can be downloaded from the following link: http://we.tl/jjpqSeTDYm.Thanks to our correspondent in Europe White-Tillet firm. 3 reports can be downloaded: HEALTHCARE POLICY & REGULATION, DRUGS & BIOLOGICS, MEDICAL DEVICES & COSMETICS/BIOCIDES.
Manufacturers of medical devices in Europe won’t need to change their labeling. Initially EN 980:2008 was about to be replaced by EN ISO 15223-1:2012 but as stated by the European Commission that won’t be the case. Some people were surprised seeing that no standard related to symbols was addressed anymore in the list of harmonized…