- “11 Steps to Obtaining CMDCAS Certification-Part I” focuses on the process of verifying the classification, selecting a registrar, and more.
Step 1: Verify Classification
There are four device risk classifications in Canada: I, II, III, and IV. If your device is Class I, then you can work with a distributor in Canada that has an establishment license. However, if your device is Class II, III, or IV, then ISO 13485 certification with CMDCAS is required as a prerequisite for a Canadian Medical Device License Application. Therefore, before you waste time and money on upgrading your ISO 13485 certification to include CMDCAS, you should ensure that your device is Class II-IV.
Each country has slightly different regulations. Often the risk classification is different between the two countries. However, in the following example, the classification is identical. If a device is an active, therapeutic device, then the device is typically classified as Class 2, as per Rule 9 of the CMDR. The rule and the rationale are identical to the EU classification of Class IIa, per rule 9 in Annex IX of the MDD. A manufacturer can confirm this classification by sending an email to the Device Licensing Division, asking them to confirm the classification rationale. Including a copy of the draft, IFU is recommended, so that Health Canada is aware of the intended use when they are verifying your classification rationale. Verification typically is completed within ten days, and there is no charge. If you need help determining the classification, please contact Rob Packard.
Step 2: Health Canada recognizes a verified Registrar
The process for becoming a CMDCAS auditor is one of the most challenging examinations that I have ever taken (http://bit.ly/Instructor-Effectiveness). However, the process of becoming a recognized registrar for CMDCAS is even more challenging. Health Canada acknowledges only 15 registrars. Therefore, ensure that your registrar is on the list first http://bit.ly/RecognizedRegistrars.
If you are selecting a critical subcontractor (i.e., “subcontractors in charge of processes which are essential for ensuring compliance with legal requirements”), you should verify that the company has a registrar that is recognized by Health Canada, as well. If not, this may result in the need for additional scrutiny of the critical subcontractor by the registrar–including the potential for an audit. If you need help selecting a registrar from the 15 recognized registrars, you should read our blog on this topic: http://bit.ly/SelectingRegistrar.
If your registrar is not one of these 15, then you will either need a second registrar, or you will need to transfer to a new registrar. The transfer process is a little different from each registrar. Still, generally, the new registrar must review previous audit reports, your certificate, and any corrective actions that are associated with the previous regulatory audit. This is typically completed in a one day audit that may be on-site or remotely conducted. The next step is to obtain a quote.
Step 3: Obtaining a Quote for CMDCAS Certification
Every registrar I know has a long application form that needs to be completed before they can provide a quote for CMDCAS certification. You will need company information about the various locations for each site covered by the quality system certificate–including the number of people, shifts, and types of activities conducted at each location. If you already have ISO 13485 certification, the quotation will be for an extension to the scope of the original quality system certification. An extension to scope audit is typically one day in duration. Upon successful completion of the audit, your company is recommended for CMDCAS certification, and the existing ISO 13485 certificate is replaced with a CMDCAS Certificate. For some companies, the scope of activities requires that you maintain your original certificate and the new CMDCAS certificate.
Once you obtain your quote(s) for upgrading to CMDCAS, then you must schedule your audit. Typically, auditors are booked at least 90 days in advance. Since the process of making upgrades to your quality system takes no more than 90 days, I don’t recommend waiting to make changes. Just go ahead and schedule the audit, and now you have a real deadline for everyone to work toward.
Part 2 of this article will explain the changes you need to make to the quality system to prepare for your CMDCAS audit.