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Grant Ramaley

FDA Compliance

MDSAP: When Is a Certificate Not a Certificate?

The quiet battle over medical device trade in Canada heats up

Published: Wednesday, September 12, 2018 - 11:00

The Dental Trade Alliance learned from its members in February 2018 that the Canadian Health Ministry (“Health Canada”) had contacted the Standards Council of Canada (SCC) and the British Standards Institution (BSI). Health Canada had ordered these certification bodies to stop issuing ISO 13485 certificates, which had been granted under the purview of the Canadian Medical Devices Conformity Assessment System (CMDCAS), with any expiration dates beyond Dec. 31, 2018.

Health Canada told them that only ISO 13485 certificates issued by the Medical Device Single Audit Program (MDSAP) would be accepted by Health Canada after that date. As many medical device manufacturers were just getting brand new ISO 13485:2016 certificates, they were stunned when they saw their new certificates had been cut off at the knees. Instead of getting a certificate with a three-year expiration date as usual, the new certificates were set to expire in less than one year.

Considering that thousands of companies pay between $10,000 and $20,000 or more for their certificates, this behind-the-scenes demand by Health Canada could have amounted to tens of millions of dollars in lost value.

After a meeting with the U.S. Department of Commerce (DOC) in early June 2018 to discuss the matter, the DOC decided to discuss the matter with Canadian trade representatives at a forthcoming World Trade Organization meeting that month. The DOC insisted it would demand the return of lost years on the ISO 13485 certificates. Was it successful?

Perhaps. It seems a little too coincidental that shortly after the DOC made its promise, BSI sent the following notice to its customers:

“The MDSAP certificates are NOT accredited and BSI recommends all clients to maintain an accredited ISO 13485 certificate to support your market needs.”... “BSI will now be issuing all CMDCAS clients a duplicate new SCC-accredited certificate without the CMDCAS logo. The new certificate will have the same scope, standard and the appropriate expiration. These will be issued as part of a project, taking into consideration the natural expiration of existing certificates.” (That would be three years, as indicated by ISO standard ISO 17021-1. Emphasis added.)

The SCC is also a full member of the International Accreditation Forum (IAF). It, like many other IAF member accreditation bodies, will provide industry with an ISO 13485 certificate that is recognized internationally. Moreover, bearing a proper internationally recognized accreditation mark will support their access to the new worldwide certification database that is being developed by the IAF.

Note: Because ISO 13485 certificates issued by the MDSAP are not accredited, they do not qualify as acceptable in the new IAF worldwide certification database.

IAF CertSeach Database: Put your company’s ISO cert on display worldwide

The IAF is working with Quality Trade of Australia to develop the largest searchable database in the world for accredited certificates. IAF has 55 accreditation bodies managing 2,000 conformity assessment bodies (CABs).

The goal is to capture all of 1.6 million accredited certificates, including more than 30,000 ISO 13485 certificates. Only certificates issued by a CAB, accredited by an IAF-member accreditation body, will be stored in this free-to-use searchable certification database.

To confirm that your ISO certificate will be accepted internationally, check for the mark of the accreditation body on the ISO certificate and see whether it was issued by one of the IAF members.

When will the database be ready? According to an announcement in June 2018 by the IAF: “The aim is to share with the IAF General Assembly in October 2018 the beta version of the database before fully launching it in 2019.”

According to the article, “Benefits of Accredited Conformity Assessment and the Supply Chain,” the chair emeritus for the IAF, Randy Dougherty, stated: “The [certification] database presents a very significant opportunity for accreditation and accredited management system certification to really stand out as a global tool for business and governments to use. I am pleased with the progress with the work which will demonstrate to the IAF membership that this will be a major asset for IAF, its members, and most important, the users of accredited certification.”

Dougherty informed the Dental Trade Alliance on Aug. 27, 2018, that “...since the signing of the contract with Quality Trade in May, the database software has been initiated, and on the 24th of August the IAF has sent letters to all IAF members ABs to initiate the process of putting data into the database. Further, the database itself is being called IAF CertSearch.”

More information about the database was announced last June and can be found here.

The Dental Trade Alliance is a member of the IAF as well as a member of the Database Management Committee.

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About The Author

Grant Ramaley’s picture

Grant Ramaley

Grant Ramaley is the director of regulatory affairs for Aseptico Inc., a manufacturer and marketer of dental support equipment in the United States and Canada since 1975.  Ramaley also is co-chairman of the Regulatory Affairs and Standards Committee for the Dental Trade Alliance, Convener for the ISO 13485 Working Group at the International Accreditation Forum, and Technical Committee Advisor to the Asian Harmonization Working Party.