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.

MEDEC: Health Canada Application Volumes on the Decline

The number of Medical Device License (MDL) and amendment applications to Health Canada’s Medical Devices Bureau (MDB) has declined over the first quarter of 2012, according to Canadian medical technology industry trade group MEDEC (registration required).

Health Canada received 1180 applications during Q1 of 2012, which is 12% lower than the average volume of applications received in Q4 of 2011 and 15% lower than the average volume of applications received over the last four quarters, MEDEC claims.

Volume versus Performance
MEDEC examined application volumes according to device class, as well: Class II applications decreased one percent from Q4 2011 to Q1 2012; Class III application volumes fell by 16%; Class IV applications decreased by five percent; and amendment applications fell by 19%.

But market authorization timeframes have also increased on the MDB’s side, according to MEDEC’s findings. Although application review target times for Class II devices is 15 days, actual review times averaged 24 days for new applications and 37 days for amendments for Q1 2012.

Target timeframes for Class III device application reviews by the MDB are 75 days, but actual times averaged 160 days for new applications and 111 days for amended applications over the first three months of 2012.

Market authorization times for Class IV devices, however, improved between Q4 2011 and Q1 2012. Although still behind target review timeframes of 90 days, new application reviews for the first quarter of 2012 fell to 163 days from 230 in Q4 2011. Amended applications for Class IV devices, however, saw increased review times—from 99 days in Q4 2011 to 123 days in Q1 2012.

While it appears that Health Canada has made some headway in terms of reviewing high-risk device applications, manufacturers of Class II and III devices still face considerable market authorization delays when it comes to medical device registration in Canada.

Markets: CanadaTags: Health Canada, MDL, MEDEC, medical device, Medical Device License

Author: Stewart EisenhartDate: May 3, 2012

MEDEC Reports Lower Application Volumes, Longer Delays at MDB

Canadian medical technology industry trade group MEDEC has found both decreasing volumes of applications sent to Health Canada’s Medical Devices Bureau (MDB) in the second quarter of 2011 as well as delayed market authorizations for the bulk of submitted applications due to recent regulatory changes.

Following Health Canada’s implementation of the Cost Recovery Act that raised user fees beginning last April, the number of Class II applications to the MDB decreased by 17% compared to the first quarter of 2011; Class III applications decreased by 33% and Class IV applications fell by 45% over the same period. Overall, applications to the MDB decreased 17% from Q1 2011 volumes.

More than 70% of Class II applications were deemed to have screening deficiencies by the MDB, attributed to fee and application form changes. Class III applicants saw even bigger delays: 95% of these applications had screening deficiencies, while more than half generated requests for more information from the MDB.

More than 95% of Class IV applications had screening deficiencies, and 55% of applications prompted additional information requests.

MEDEC acknowledges that drawing any conclusions regarding systemic market authorization delays at the MDB would be premature given how recently Health Canada’s revised fee structures went into effect. In the short term, however, applicants unaccustomed to the Canadian market’s new fee requirements should not be surprised by longer-than-expected review times.

Markets: CanadaTags: Health Canada, MDB, MEDEC, Medical Devices Bureau

Author: Stewart EisenhartDate: September 27, 2011

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

Canada’s MDB Struggled to Meet Market Authorization Timelines in 2010

According to MEDEC, the Canadian medical device industry trade association, Health Canada’s Medical Devices Bureau (MDB) faced a persistent backlog last year when it came to processing market authorization applications in a timely manner.

MEDEC characterizes the backlog as primarily an effect of increasing application volumes: For the whole of 2010, the MDB saw a 10% increase in application volumes, with new versus amendment applications making up about 60% of that increase.

Class II applications represent three-fourths of MDB’s new application volumes, and increased nine percent from 2009. Class III new applications actually decreased by one percent, while Class IV new applications increased by 18%.

MDB’s performance in terms of meeting approval timelines was a mixed bag in 2010, according to research published by MEDEC in its Pulse newsletter. For Class II devices, the regulator improved its processing times for new applications compared to 2009, and was able to approve amendment applications within target times.

Class III and Class IV market authorizations, however, typically took twice the MDB’s target time (160 days instead of 80 for Class III applications, and 180 days instead of 90 for Class IV applications).

Although MEDEC does not directly suggest any solutions to the backlog in its newsletter, there are two obvious approaches to take in order to speed up MDB’s application processing: Either advocate more resources to Health Canada in order to handle growing volumes, or amend the Canadian regulator’s methods for processing market authorization applications. Throwing money at this particular problem may prove easier than trying to amend regulatory policy.

Markets: CanadaCategories: Regulatory ComplianceTags: HC, Health Canada, MDB, MEDEC, Medical Devices Bureau

Author: Stewart EisenhartDate: February 2, 2011