Health Canada has issued a directive to all CMDCAS-recognized registrars clarifying appropriate issuance of ISO 13458/13488 registration under the CMDCAS program to medical device manufacturers.

According to the directive, it’s inappropriate to issue registration under the CMDCAS program in the following cases:

• Class I manufacturers, importers, distributors or subcontractors (who do not hold or intend to apply for a Health Canada product license as the named manufacturer)
• Registration under CMDCAS is only appropriate when an entity is the manufacturer of class II, III and/or IV devices and holds or intends to apply for Canadian product licenses under the name and address of the manufacturer.
• Registrations under CMDCAS of entities other than the legal manufacturer, as defined in the Canadian medical device regulations, in contravention of the terms and conditions for recognition under section 32.5 of the regulations. Reference Medical Device Regulations, which is interpreted by Health Canada in its policy on CMDCAS (Q90R0)
• When registration under CMDCAS has been issued, and it is deemed that registration under CMDCAS is inappropriate, the CMDCAS recognized registrar should contact the registration holder and make arrangements to withdraw the registration under CMDCAS. Any manufacturer effected by this Health Canada directive would still be eligible to hold ISO 13488/13485 registration outside of the Health Canada CMDCAS program.

CMDR defines "manufacturer" as the company that sells a medical device under its own name or trademark, design, trade name or other name or mark owned or controlled by the persons, and that is responsible for designing, manufacturing, assembling, processing, labeling, packaging, refurbishing or modifying the device, or for assigning to it a purpose, whether those tasks are performed by that company or on its behalf.

For more information e-mail medical.devices@bsiamericas.com.

Source: BSI Medical Devices E-Mail Update