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.

Medical Device Trade Groups Sign On to Global Compliance Statement

Nine medical device industry associations have signed on to the Global Compliance Statement on Interactions Between Medical Technology Companies and Healthcare Professionals (HCPs), a document intended to promote ethically sound interactions between the groups’ member firms and health care providers.

The Advanced Medical Technology Association (AdvaMed), Eucomed and the European Diagnostic Manufacturers Association (EDMA) first signed on to the document in 2010; six additional groups—the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR), the International Medical Devices Manufacturers Association (IMEDA), MEDEC, the Medical Technology Association of Australia (MTAA), the Medical Technology Association of New Zealand and the South African Medical Device Industry Association (SAMED)—signed the document during the 2011 International Medical Device Industry Compliance Conference in London, according to a Eucomed press release.

Specific efforts the associations have agreed to undertake include pushing their respective members to adopt compliance policies and procedures in line with industry codes; providing guidance to industry regarding ethical business conduct when engaging with health care professionals; keeping members informed of relevant laws, regulations and professional codes that impact how firms interact with health care professionals; and collaborating to increase adoption of ethical codes of conduct on a global scale.

Buy-in of the global compliance statement among a significant number of trade groups representing various medical device markets no doubt reflects a more advanced and nuanced level of maturity of the industry as a whole—but also the need for member companies to establish adequate processes and procedures in the face of growing regulatory interest.

Markets: WorldwideTags: advamed, compliance, edma, Eucomed, MEDEC, medical device, mtaa

Author: Stewart EisenhartDate: May 19, 2011

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.