Canada not auditing compliance with ISO 13485/88 based on agency's CMDCAS: but joint inspections possible.

TORONTO -- Health Canada's Therapeutic Products Directorate (TPD) hopes the nation's relatively new amendments to its Medical Device Quality System requirements will boost compliance with the International Standards Organization's (ISO) standard for device QS (ISO 13485 and 13488), but the agency will not inspect device firms based on the Canadian Medical Devices Conformity Assessment System (CMDCAS)

Don Boyer, acting director of the TPD Medical Devices Bureau's Device Evaluation Division, told a Regulatory Affairs Professionals Society meeting here July 26 that inspectors from his agency "do not audit against CMDCAS requirements."

Instead, he said, "auditors look for implementation and effectiveness of QS procedures, and inclusion of relevant MDR [Medical Devices Regulations] requirements in the manufacturer's QS (ref. clause 4.2.1 of ISO 13485 and 13488." Boyer said "they audit the manufacturer against the elements of an ISO standard according to ISO auditing practices."

However, he also said there is a possibility for manufacturers to have joint QS audits performed by one organization in order to meet various regulatory schemes.

The primary intent of the CMDCAS is to support the ISO 13485/13488 QS provisions of the Medical Devices Regulations. It applies only to third-party registrars, Boyer said. The CMDCAS is used to classify devices; assess scientific and technical data, including those related to the safety and effectiveness of devices; verify compliance of a manufacturer to the provisions of the MDR; and "act as Health Canada inspectors or perform any related duties," he explained.

Patterned after the European Union's system of conformity assessments, Health Canada requires medical device manufacturers to get a "quality system certificate" as evidence of compliance with the appropriate regulatory quality-system requirement, and to obtain certificates from private "recognized registars," which are similar to notified bodies in the EU.

Boyer cited two key amendments to Canada's QS regulations that are significant to achieving compliance:

* Schedule 1258, Amendment SOR/2001-217, which was enacted June 14, 2001, but postponed for agency enforcement until Jan. 1, 2003.

* Schedule 1293 Amendment SOR/2003-173, enacted May 15, 2003. Boyer said the sections that were modified were: 1, 32(2)(f), 32(3)(j), 32(4)(p), 43(1)(b). New sections also were added: 32.1 to 32.5 and 43.1.

These changes involved moving from attestation to providing quality system certificates from registrars. He said the requirement for QS certificatess will apply to manufacturers already holding medical device licences, and will include requirements on how and when to submit and maintain valid certificates on file at Health Canada. Boyer added:

"Regulatory QS provisions apply to all manufacturers of Class II, III and IV medical devices--Canadian and foreign. Regulatory QS provisions do not apply to importers and distributors unless they meet the definition of a manufacturer."

A valid ISO 13485 or 13488 QS system certificate from a CMDCAS-recognized registrar will be required for manufacturers of Class II, III and IV existing and new medical device licenses by Health Canada. The standards against which registrars are authorized by Health Canada to perform audits are:

* ISO 13485:1996, ISO 13488:1996

* CAN/CSA ISO 13485:1998 and CAN/CSA

* ISO 13488:1998

* ISO 13485:2003

* CAN/CSA ISO 13485:2003

FDA audits do not replace need for certificates

What is not accepted by Health Canada are: ISO 9001:2000 certificates; QS certificate issued to other national or regional standard (e.g., IS EN ISO 13485-2000); FDA inspections; and manufacturer self-declarations of conformity, Boyer explained.

Information that device firms must provide to get certificates include labeling, conditions of use, description of device and materials in manufacturing and packaging, method of sterilization, summary of studies that manufacturers rely upon to ensure safety and effectiveness, marketing history, and problem reports and recalls, Boyer added.

He said the intended outcome of the CMDCAS is that "Health Canada will have confidence in manufacturers' quality systems and their effective use of government resources, plus better monitoring of devices on the Canadian market."

While Boyer said recognized registrars must be sanctioned by Health Canada, most, so far, are notified bodies in Europe. As of July, he said, 14 such companies are recognized by TPD, and an additional recognition from American Manufacturing Trade Action Coalition (AMTAC) was still pending as of July 26. One new application was received after Jan. 1, 2003, meaning TPD is not accepting certificates from that applicant, and two registrars have withdrawn from the program, Boyer added.

The recognized registrars and third party auditors are:

* TUV America

* BSI Inc.

* Underwriters Labratories, Inc.

* Intertek

* QMI 

* SGS

* TUV Rheinland of North America

* Orion Registrar, Inc.

* KEMA 

* IQSR

* NSAI 

* DQS

* RWTUV 

* G-MED

The list and contact information is available on the websites of Health Canada and Standards Council of Canada.

The information on Health Canada's website will include: the name and address of registrar; the general phone, fax and email addresses of office that is recognized by Health Canada; and the status of the registrar with Health Canada (recognized under section 32.5 of MDR).