Worldwide Medical Device Regulatory Updates
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.
The enforcement unit of the Competent Authorities overseeing medical device market surveillance in the European Union has published new guidance for Instructions for Use (IFU) for reusable and resterilizable medical devices following several non-conformities reported across member states.
An effective medical device distribution plan for the Middle East requires appreciation for business culture and practices unique to the region, as well as for distinct market characteristics for countries such as Turkey, the Kingdom of Saudi Arabia and Egypt.
South Africa’s Department of Health has released new draft regulations for medical devices and IVDs that accompanies proposed rules issued by the government in 2014.
Russian medical device market regulators have eased registration and market entry requirements for low-risk Class I devices, while at the same time formalizing procedures for certain registration amendments and changes to Instructions for Use (IFU).
The Australian Therapeutic Goods Administration (TGA) has officially ended the three-year transition period for manufacturers of certain joint replacement devices to apply for reclassification of their products from Class IIb to Class III.
Although the European Union has a uniform process, CE Marking, in place to allow registration and marketing of medical devices across all member states, distribution of devices requires regional expertise. In this Emergo podcast, we explain how to identify and vet European device distributors.
The China Food and Drug Administration (CFDA) will begin a new program of unannounced inspections beginning September 1, 2015 for medical device manufacturers registered to market their products in the country.
When COFEPRIS will Accept ISO 13485 in Lieu of EIRs for US Devices Seeking Expedited Mexico Registration
Emergo consultants in Mexico City have learned additional information regarding COFEPRIS requirements for US FDA-cleared or approved devices undergoing expedited registration in Mexico.
Emergo consultants in Seoul have conducted a thorough analysis of draft Ministry for Food and Drug Safety (MFDS) revisions to South Korean medical device and IVD regulations announced earlier in 2015 to highlight major changes between current and proposed new requirements.
The Medical Device Authority (MDA), Malaysia’s medical device market regulatory agency, has extended its deadline for temporary expedited device registrations to June 30, 2016.