Regulatory affairs topics affecting medical device registration in certain markets. Covers pre-market and post-market as well.
borderline and classification medical devices: UPDATED MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.16 (07-2014) Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable…
Statement of Cooperation Among FDA – TGA – ANVISA – HPFB: MDSAP pilot According to the SOC (Statement of Cooperation), the “Participants” composed of the The United States Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Surveillance Agency (ANVISA), and the Canadian Health Products and Food Branch (HPFB) aims…
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…
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.