Canada's Medical Instrument Regulations (MIR) mandate manufacturers' justification of a quality management system that satisfies the requirements of Canadian Standard CAN/CSA ISO 13485 for Class II through IV medical instruments (according to the Canadian nomenclature).
The quality system must incorporate features specific to the body of MIR regulations. Moreover, it must be certified by a so-called "registrar" body, which itself has been accredited by the Canadian Standards Council in strict compliance with the program entitled CMDCAS (for Canadian Medical Devices Conformity Assessment System), as recognized by the Canadian Health Ministry ("Health Canada").
LNE/G-MED, one such registrar body, is recognized by Health Canada. In accordance with the CMDCAS program, LNE/G-MED is empowered to deliver the quality system certificates necessary to apply for manufacturer certification from Health Canada.
Since 2014, Health Canada has allowed for certificates relative to both programs, depending on the manufacturer's preference, to be appended to the certification applications submitted for Class II, III or IV medical devices.
As of January 1st 2019, only those certificates validated within the scope of the MDSAP program shall be accepted. This modification means that all companies holding a certification issued under the purview of the CMDCAS program must, beginning now, anticipate their transition to the MDSAP program.
From October 1st 2017 forward, LNE/G-MED will no longer be proposing the CMDCAS certification framework. Also of this date, in order to apply Health Canada's decision under optimal conditions, CMDCAS certificates will only be acknowledged as part of a program transition step from CMDCAS to MDSAP. No new CMDCAS certification contracts will be drawn up.
For companies currently holding a CMDCAS certificate, a commercial contract will define:
Begin your application to obtain certification within the scope of the CE marking program by requesting the "Quality Management System Certification" information questionnaire, with a simple click on the "Obtain a quote" button.
For more information on the certification process, a no-cost webinar is available: