therapeutic goods (medical devices)

TGA Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy Continue reading...

Comments on both the Therapeutic Products Bill and the Therapeutic Products Regulatory Scheme: Consultation document. Continue reading...

Health Canada - Proposed Changes to the Therapeutic Products Directorate’s List of Recognized Standards for Medical Devices Proposed Changes to the Therapeutic Products Directorate’s List of Recognized Standards for Medical Devices - Canada.ca

Some Background: I was asked yesterday by Kim Trautman of FDA to participate in the Medical Device Single Audit Program (MDSAP). The company for which I'm Regulatory Manager has been a participant in the Voluntary Audit Report Submission Pilot Program (VARSP) for the past two years, and MDSAP...

Dear All, Does anyone have or have seen a comparison of requirement for GMP (or quality system) of different products, food, drug, cosmetic, medical device, and biologics. Many thanks,

I've recently been asked to CE mark a product for a company (customer) based in America, who are the manufacturer of the product in question and also want to retain the term "manufacturer" in line with the CE mark. They need the CE mark approval in order to get TGA registration as their current...

Hi all, Here is an update on the future ANZTPA initiative: http://www.tga.gov.au/about/international-anztpa-factsheet.htm Cheers, Ronen.

Hi, I am trying to figure out what Combination Products are approved in the EU. The definition for Combination products in the EU is a "combined advanced therapy product’ is defined as one that incorporates as an integral part one or more medical devices, or active implantable medical devices...

Team: I just received this notification which I found worth sharing here at the cove. Actually I am just copying a portion because there was some publicity related involved, so I tried to keep only the part w/o such commercial claims: "We are writing to communicate three important changes to...

I would like to enquire whether any of the forum members are aware of a system for the classification of surgical items. Such a classification may allow us to compare prices of surgical items relative to their quality and therapeutic use within a category. This may assist in developing a...