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.

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

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.

Markets: CanadaCategories: Regulatory ComplianceTags: HC, Health Canada, inspections, MDEL, MDL

Author: Stewart EisenhartDate: August 15, 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

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

HC Clarifies Significant Change Guidance

Health Canada has published new guidance defining when manufacturers’ altering of their Class III and Class IV devices constitutes “significant change,” affecting medical device licenses.

The regulator’s Guidance for the Interpretation of Significant Change has important ramifications for manufacturers whose proposed changes to their products qualify as significant changes, because that qualification requires submission of license amendment applications to HC.

The guidance replaces the 2003 Guidance for the Interpretation of Significant Change of a Medical Device, and is intended to clarify (if not tighten) requirements in Canada’s Medical Device Regulations pertaining to how Class III and IV devices are licensed for sale in the country.

A three-phase assessment tool comprising general principals in identifying significant changes, flow charts to support manufacturers’ decision making, and a list of significant and non-significant examples is provided in the new guidance document.

Key provisions of the new guidance:

If a manufacturer determines it has made a significant change to a medical device, the modified device can only be introduced to the Canadian market upon receipt of an amended medical device license from HC
Any labeling change adding a contraindication, warning or precaution affecting public health should be immediately implemented along with submission of a license amendment application to HC
Manufacturers must document any and all changes made in their quality management systems, and report non-significant changes to devices must be reported to HC during the annual license renewal process.

Markets: CanadaCategories: Regulatory ComplianceTags: HC, Health Canada, MDL, Medical Device License, Significant Change

Author: Stewart EisenhartDate: January 27, 2011

HC Makes Some Allowances for Paperless Medical Device Labeling

Health Canada has issued a new interpretation of Canada’s Medical Devices Regulations allowing electronic labeling for medical devices sold exclusively to medical professionals.

The usual rules apply: All medical devices must be labeled in order to be sold or imported, and all labels—including electronic ones—must be legibly and prominently displayed. Manufacturers now have the option of providing only e-labeling via CD or DVD for devices not sold to the general public. For Class IV medical devices and IVDs that do not fall under the “near patient IVDD” definition, label information may be provided in downloadable format from an “easily navigable” website.

Manufacturers using e-labeling are obliged to provide paper copies of that information upon request to device users. Furthermore, manufacturers must provide attestations that e-label details match word-for-word those included on the paper labels of their devices.

The e-labeling interpretation went into effect immediately upon its issuance on November 9, 2010.

Markets: CanadaCategories: Regulatory ComplianceTags: canada, HC, Health Canada, label, labeling, medical device, paperless

Author: Stewart EisenhartDate: December 13, 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.