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. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Single Medical Research Regulatory Framework Championed in the UK

The UK’s Academy of Medical Sciences has issued a new report recommending the consolidation of medical research regulations and governance under a single entity.

The Academy’s report, “A new Pathway for the Regulation and Governance of Health Research,” includes five key components: the creation of a new Health Research Agency (HRA) to oversee all medical research activities in the UK; the establishing of a new National Research Governance Service within the HRA to expedite approval of research studies; improving the overall environment within the UK for clinical trials; improving access to patient data for more effective research; and embedding a culture valuing research within the National Health System.

Access to the Academy’s fully report, as well as responses to the proposal, are available here.

A more well-oiled research regulatory infrastructure could make the UK a more attractive market in which to conduct clinical trials and gain approval for medical device and IVD products.

Markets: EuropeCategories: Regulatory ComplianceTags: clinical trials, medical research, regulations, UK

Author: Stewart EisenhartDate: January 11, 2011

Mexican Market Entry Just Got Easier

Medical devices and IVD products able to pass muster with the US FDA and Health Canada may now enjoy de facto access to Mexico as well thanks to recent regulatory reforms.

The Mexican Health Authority’s Federal Commission for Protection against Sanitary Risks (COFEPRIS) has put into effect new rules recognizing medical device authorizations for Class I, II and III commercialized products in the US, as well as for Class II, III and IV commercialized products in Canada. A new eJournal article from Emergo Group explains the specifics of the new rule that COFEPRIS has made available, but many details remain forthcoming. Suffice it to say that going forward, it appears as though medical device and IVD manufacturers already authorized to sell their products in the US or Canada will enjoy a two-for-one (or three-for-two) deal when it comes to achieving regulatory approval in all three major North American markets.

Bottom line: Depending on the classification of their products, medical device and IVD manufacturers already authorized by either the FDA or Health Canada can extend their marketing to Mexico without any significant new regulatory hurdles.

Markets: MexicoCategories: Regulatory ComplianceTags: COFEPRIS, FDA, Health Canada, Mexico, regulations

Author: Stewart EisenhartDate: December 10, 2010

HC Sets Compliance Deadlines for Revised Software Requirements

Software manufacturers whose products fall under Health Canada’s medical device classification system have until February or September 2011 to comply with new requirements set forth by the regulator.

According to HC clarifications announced December 3, 2010, software developed to view medical-related images or data is to be assigned Class I classification according to Rule 12 of Canada’s Medical Device Regulations. Software involving imaging, data manipulation, measurements or identification capabilities now falls under Class II classification based on Regulations Rule 10 (1).

In terms of compliance with HC’s new guidelines, medical device software manufacturers will need to adhere to Section 9 of the Regulations. Class I software manufacturers must ensure compliance by February 1, 2011; Class II manufacturers must ensure compliance and obtain licenses by September 1, 2011.

Bottom line: The new HC requirements present a more consistent approach to medical device classification in Canada, and should present no significant operational burdens for affected software manufacturers in terms of compliance.

Markets: CanadaCategories: Regulatory ComplianceTags: canada, compliance, HC, Health Canada, regulations, software

Author: Stewart EisenhartDate: December 8, 2010

Resource for overview of medical device regs

A lot of people know that the US Department of Commerce publishes short research reports on the medical device industry in specific countries, but it's worth repeating in case you have not visited in some time. You can read regulatory process overviews on 20+ countries at the DOC website. If you want to read the actual regulations for a specific countries, we have many of them posted in our Learning Library on our website.

Markets: WorldwideCategories: Regulatory ComplianceTags: DOC, regulations

Author: Chris SchorreDate: March 13, 2009