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's 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.

August 26, 2014 by Stewart Eisenhart
Emergo colleagues in China have provided additional analysis of new requirements from the China Food and Drug Administration (CFDA) regarding in vitro diagnostic (IVD) device registrations. According to CFDA Administrative Order No. 5, all Class I, II and III IVDs imported into China will have to undergo new CFDA registration requirements beginning October 1, 2014.
August 20, 2014 by Stewart Eisenhart
The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessments from several Notified Bodies. The TGA move could cause delayed Australian market entry for manufacturers that have used these Notified Bodies for certification. The following eight Notified Bodies were identified in the new TGA announcement:
August 18, 2014 by Stewart Eisenhart
A new pilot program planned by the US Food and Drug Administration is being planned to develop tools for more effective and efficient reviews of medical device premarket applications.
August 15, 2014 by Stewart Eisenhart
Chinese medical device market regulators have more clearly defined the responsibilities of in-country representatives and limited exemptions for clinical evaluations in new rules, according to Emergo Group colleagues in Beijing and Shanghai. In Administrative Order No. 4, The China Food and Drug Administration (CFDA) has listed the duties of foreign manufacturers’ authorized representatives, known as Legal Agents, as follows:
August 14, 2014 by Stewart Eisenhart
The US Food and Drug Administration plans to exempt certain medical devices from 510(k) premarket notification requirements due to what the agency considers their well-established safety and effectiveness. For the time being, the FDA will no longer enforce 510(k) compliance for devices listed in its draft guidance. The agency plans to issue a final rule that will formally exempt those devices from premarket notification requirements.
August 11, 2014 by Stewart Eisenhart
Emergo Group colleagues in China have provided additional details on recently published changes to the China Food and Drug Administration’s (CFDA) medical device registration process. CFDA Administrative Order No. 4 covers new and revised requirements for Class I, II and III device registrations in China that will take effect October 1, 2014. Class I filings
August 7, 2014 by Stewart Eisenhart
Increasing use of medical devices used outside of healthcare facility settings has prompted the US Food and Drug Administration to issue new guidance on design considerations for manufacturers of such “home-use” products.
August 5, 2014 by Stewart Eisenhart
New guidance from the US Food and Drug Administration updates the agency’s recommendations for what to include in 510(k) premarket notification submissions, with particular emphasis on Substantial Equivalence (SE) applications and proper predicate device identification. Six key steps in the 510(k) SE decision process are laid out in the new guidance: 
August 4, 2014 by Stewart Eisenhart
Chinese medical device market regulators have published long-awaited updates to medical device as well as in vitro diagnostic device and labeling requirements that will go into force October 1, 2014. First, China Food and Drug Administration (CFDA) Administrative Order No. 4 (link in Chinese) encompasses multiple areas of medical device registration, in-country representation, clinical trial requirements and related submission procedures.
July 30, 2014 by Stewart Eisenhart
The Japanese government has set an enforcement date  of November 25, 2014 for revised laws that regulate the country’s pharmaceutical and medical device markets.