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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
Health Canada Amends Lists of Medical Device Standards
Health Canada has announced changes to its list of recognized list of medical device standards used to demonstrate safety, effectiveness and labeling requirements of the Canadian Medical Devices Regulations in order to foster more efficient device reviews.
The changes to the Therapeutic Products Directorate’s List of Recognized Standards for medical devices have specifically been altered as follows:
- 28 new standards will be added to the List
- 10 new editions of currently recognized standards will replace previous editions
- One standard will be deleted from the List
- Two standards will be superseded
These changes are part of Health Canada’s ongoing effort to ensure standards it requires licensed medical device manufacturers to follow are up to date.
Markets: CanadaTags: canada, Health Canada, MDEL, MDL, Medical Device License, Therapeutic Products Directorate
Author: Stewart EisenhartDate: April 16, 2012
New Health Canada Fees Set for April 1, 2012
Canadian medical device regulator Health Canada plans to increase its fees to manufacturers starting April 1, Emergo Group’s Canada office has learned.
For Class II medical device license application reviews, fees will increase from $350 to $357.
For Class III medical device license application reviews, HC plans the following increases:
- License application: from $5,050 to $5151
- License application for near patient IVD device: from $8,600 to $8,772
- License amendment application for significant manufacturing change: from $1,270 to $1,296
- License amendment application for significant change affecting device classification: from $4,730 to $4,825
Fees for Class IV medical device license application reviews have also increased as follows:
- License application: from $11,750 to $11,985
- License application for device containing human/animal tissue: from $10,960 to $11,180
- License application for near patient IVD device: from $20,030 to $20,431
- License amendment application for significant manufacturing change: from $1,270 to $1,296
- License amendment application for significant change affecting device classification: from $5,390 to $5,498
Finally, Medical Device Establishment License (MDEL) fees are increasing from $7,200 to $7,344, and renewal fees will increase to $337 per year. HC will make new application and amendment forms available starting April 1. Emergo Group will provide further details as we get them.
Markets: CanadaTags: Health Canada, MDEL, MDL, medical device establishment license, medical device license application
Author: Stewart EisenhartDate: March 23, 2012
HC Extends Premarket Review E-Submission Program to Class III Devices
Starting November 1, 2011, Health Canada will extend a pilot program requiring both paper and electronic submissions of premarket review documents for Class IV medical devices to Class III devices, as well.
According to a new HC guidance for industry, the pilot program’s extension to Class III applications are part of the regulator’s ongoing transition to accepting stand-alone electronic submissions. The guidance covers medical device license applications as well as medical device license amendment applications for Class III and IV medical and in vitro diagnostic devices. The program also applies to documents including Screening Deficiency Letter responses, Clarification Requests and Additional Information Letters associated with premarket review submissions.
The HC guidance lists file and data formatting, naming and structuring requirements and suggestions, and also requires letters of attestation from manufacturers verifying that the content of their electronic submissions matches that of their paper filings.
Electronic premarket review submissions will help expedite the device review process, HC argues, and improve data management as well.
Markets: CanadaTags: HC, Health Canada, IVD, medical device, Medical Device License
Author: Stewart EisenhartDate: October 26, 2011
HC Plans Wider Use of Foreign Reviews in Device Licensing Process
Health Canada has published draft guidelines outlining plans to make broader use of medical product reviews conducted by foreign regulators in its own review processes in order to better meet performance targets and improve regulatory assessments.
The regulator plans a pilot phase for specific products—including new applications for Class III and IV medical devices—starting October 2011 and running until March 2013 in which Canadian reviews of medical devices, pharmaceuticals and other medical products will incorporate data from foreign reviews. Comments on the proposal will be accepted until March 31, 2013.
Within the medical device sector, HC’s proposal would affect Class III and IV Licence Applications as well as Class III and IV Licence Amendment Applications.
According to the HC guidelines, device reviews from the US FDA and European Medicines Agency are preferred, but HC may also consider foreign reviews from other regulator such as Swissmedic or the Therapeutic Goods Administration.
The new proposal does not alter submission requirements for Canadian market applicants, and HC will not grant market authorizations based solely on foreign reviews. In addition, applicants are not required to submit foreign reviews as part of their Canadian review processes.
HC lists four methods by which foreign reviews may be incorporated into Canadian reviews of devices:
- Canadian regulatory decisions based on critical assessments of foreign reviews
- Canadian reviews based on critical assessments of foreign reviews, referring to data filed in Canada as necessary; final regulatory decisions based on Canadian reviews
- Canadian reviews based on critical assessments of data filed in Canada, using foreign review data as added references
- Canadian regulatory decisions based on Canadian reviews because foreign review data is not relevant
For Class III and IV medical device applicants submitting foreign reviews along with their data packages, foreign reviews should be listed in data package tables of contents and included as appendices to data packages.
Markets: CanadaTags: foreign review, HC, Health Canada, medical devices
Author: Stewart EisenhartDate: September 30, 2011
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
HC Amends Procedure for Mandatory Problem Reports
Canadian medical device market regulator Health Canada will begin requiring manufacturers and importers to send Mandatory Problem Reports (MPRs) to its Health Canada Vigilance-Medical Device Program Reporting Program (CVMD), beginning October 3, 2011.
The change will impact firms with Medical Device Establishment Licenses and Canadian Medical Devices Conformity Assessment System accreditations.
Responsibility for HC’s MPR procedure has moved from the regulator’s Health Products and Food Branch Inspectorate to its Marketed Health Products Directorate. The CVMD falls under HC’s Canada Vigilance program for post-market surveillance of health products.
From October 3rd, device manufacturers and importers should send MPRs to the following address:
Canada Vigilance-Medical Device Problem Reporting
Marketed Health Products Directorate
Health Canada
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
Fax: 613.954.0941
Email: mdpr [at] hc-sc [dot] gc [dot] ca
HC is also updating associated documents—the Guidance Document for Mandatory Problem Reporting of Medical Devices (GUI-0059) and the Mandatory Problem Reporting Forms for Industry (FRM-0237, FRM-0238 and FRM-0255) in accordance with these procedural changes; the updated documents will be available on HC’s MedEffect website on October 3rd.
In the meantime, manufacturers and importers should continue submitting MPRs to the Health Products and Food Branch Inspectorate. For questions regarding the procedural change, firms should contact the Canada Vigilance program via email (canadavigilance [at] hc-sc [dot] gc [dot] ca) or phone (613.957.0337).
Markets: CanadaTags: CMDCAS, Health Canada, MDEL, MPR, post-market surveillance, postmarket surveillance
Author: Stewart EisenhartDate: September 16, 2011
Health Canada Proposes Risk-Based Inspection Model
Health Canada is seeking comment from industry on a proposed risk-based inspection model for medical device manufacturers active in the Canadian market.
The regulator has requested comment specifically on how to assess individual medical device establishments’ risk, and on appropriate inspection cycles for varying levels of risk.
HC’s current framework for inspecting firms holding Medical Device Establishment Licenses (MDEL) limits the role of risk in determining which MDEL holders are subject to inspection, focusing inspection cycles primarily on the number of MDEL holders and their activities. Under the proposed new inspection model, two license holders pursuing similar activities would have different inspection cycles based on their particular levels of risk.
HC has proposed four options for how to establish risk-based inspection cycles:
- Quantitative risk-based approach: HC would use a series of risk factors—compliance history, mandatory problem reports and recalls, for example—to classify and score an MDEL holder. Higher risk scores would result in more frequent inspection cycles.
- Frequency determined by activities conducted and prior inspection records: A license holder’s activities being conducted—manufacturing, importing or distributing—as well as the firm’s previous inspection results determine inspection cycle frequency.
- Facility and device class: HC would employ a matrix to cross-examine a license holder’s type of facility and device class, and then determine how often that firm should be inspected.
- Intrinsic and compliance risk: Combining aspects of the first three approaches, this three-step option would first determine levels of risk intrinsic to a license holder’s activities (highest risk is assigned to manufacturers versus importers or distributors). Then, HC would consider the firm’s compliance risk based on its prior inspection record. Third, intrinsic and compliance risks would be adjusted based on other risk factors and inspection cycles would be determined accordingly.
Comments are due by November 16, 2011.
New Guidance from Health Canada on Medical Device License Renewal
Health Canada has published new guidance for manufacturers of Class II, III and IV medical devices on the Medical Device License renewal process.
The Medical Device License renewal process entails manufacturers licensed to sell their products in Canada notifying Health Canada annually before November 1 if information submitted with their license applications have not changed.
Right-to-sell fees incurred by license holders for renewals depend on individual firms’ annual gross revenues. For firms with annual revenues of $20,000 or less from sales of medical devices in Canada, a right-to-sell fee is assessed at $50 according to Section 48. (1) (a) of the Free Regulations; firms with annual revenues above $20,000 will be charged $330.
License holders will see right-to-sell fees increase by two percent starting April 1, 2012.
For manufacturers that haven’t completed a full calendar year of selling in the Canadian market by the time license renewals are due, HC will defer their right-to-sell fees until the end of that year, according to the guidance.
The new guidance document, “Guidance Document – Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices,” replaces “Guidance for Industry – Medical Device Licence Renewal” published August 23, 2005.
Markets: CanadaTags: canada, HC, Health Canada, MDL, medical device licence, Medical Device License
Author: Stewart EisenhartDate: July 25, 2011
Health Canada Elaborates on IEC 60601-1 Compliance Recommendations
Health Canada has provided recommendations for medical device manufacturers whose products must comply with the latest iteration (Third Edition) of the IEC 60601-1 medical electrical equipment safety standards.
According to an HC official, licenses already issued for medical devices meeting requirements of the Second Edition of IEC 60601-1 will remain valid after 2012, as will licenses for devices in compliance with standards related to the Second Edition.
New equipment, however, may have to meet Third Edition requirements—even if manufacturers already hold licenses for compliance with the Second Edition—depending on how individual provinces enforce Canada’s Electrical Safety Code.
From June 2012, manufacturers applying for significant change amendments to their device licenses previously complying with the Second Edition will be asked to update their compliance to meet Third Edition requirements, according to the official. The regulator also encourages all manufacturers to comply with the Third Edition as quickly as possible to ensure up-to-date electrical safety of their products.
Markets: Canada, ChinaTags: Health Canada, IEC 60601-1
Author: Stewart EisenhartDate: July 1, 2011
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