“11 Steps to Obtaining CMDCAS Certification-Part 2” focuses on the process of updating the quality system and preparing for your certification audit. The first three steps focus on classification and selecting a registrar.
Steps 4: Writing a Licensing Procedure
Nowhere in the Canadian Medical Devices Regulations (CMDR), or ISO 13485, does it require that you have a procedure for licensing or writing your technical documentation. However, most of the registrar auditors I have observed expect to see a procedure for this. You can reference Health Canada’s guidance documents (http://bit.ly/CanadianGuidance) and the CMDR (http://bit.ly/CanadianMDR), but that’s not enough. Typical audit questions I see on regulatory checklists include:
- Is the company required to notify Health Canada of changes to the certificate within 30 days?
- Is the classification rationale documented?
- What is the procedure for maintaining technical documentation for Health Canada?
- Is there a procedure for identifying significant changes that require notification of Health Canada (http://bit.ly/Canada-Significant-Change)?
Step 5: Mandatory Problem Reporting (MPR)
Some companies choose to have one procedure for adverse event reporting that covers all the countries that they distribute the product(s) in. However, I recommend having a separate procedure for each country that is shorter and will require updates less often. It’s a personal preference, but I find people are intimidated by a longer, combined procedure. The following are the key elements for the MPR procedure:
- decision tree for when to report
- timescale for reporting deadlines
- form references
- address for reporting
- reminder to report the event to the US FDA if the product is also sold in the USA
Step 6: Recall Procedure
Unlike the MPR procedure, I recommend having only one recall/advisory notice procedure to comply with Health Canada’s requirements and the rest of the worlds’ regulatory requirements. I typically choose this approach, because the recall/advisory notice procedure is less complex than the adverse event reporting procedures. The key element I look for in this procedure is the address for notifying Health Canada of a recall because there is a different address in each region of Canada.
Step 7: Finding a Distributor
A Canadian Medical Device License is a license to distribute medical devices. Only Class I devices require an establishment license. Therefore, your company will be able to sell directly to physicians prescribing your device if you have a Class II, III, or IV Medical Device License. If you choose to use a distributor in Canada, the distributor must meet the requirements for record-keeping, and demonstrate the ability to conduct a recall, if necessary. Often, this is done by having a quality agreement in place, which stipulates the retention of distribution records. Also, your company should conduct a mock recall once distribution has begun. This will ensure that the distributor is compliant with the requirements for maintaining distribution records. The instructions for conducting a mock recall will be included in the revisions to the recall/advisory notice procedure described in Step 6.
Step 8: Training
The most common root cause of audit findings related to the CMDR is a lack of understanding with regard to the regulatory requirements. A better procedure can help, but there is no substitution for training on the CMDR. The CMDR is relatively easy to understand when compared to European Regulations, and the CMDR is shorter in length than US FDA regulations. However, most people have a lot of difficultly understanding the jargon of medical device regulations unless they are a regulatory expert. Therefore, it is essential to develop training that summarizes the CMDR for anyone in your company that will be involved with complaint handling, adverse event reporting, recalls and regulatory submissions–including design changes.
Medical Device Academy has a recorded webinar designed explicitly for company-wide training when companies are preparing for CMDCAS certification: http://bit.ly/CMDCAS-webinar. The cost of the webinar is $129, and there is a 10-question exam to verify the effectiveness of training. The exam costs $49 to grade, correct answers are explained for each question, and a certificate is issued for a passing grade of 70% or more.
Step 9: Internal Auditing
Your registrar will verify that you conducted an internal audit of the quality system for compliance with applicable sections of the CMDR. This can be performed by one of your internal auditors or a consultant. The audit can be completed on-site, but sometimes a remote desktop audit will suffice. Since there will be no records of distribution, licensing, complaints, or recalls before the CMDCAS certification–there is little value in conducting an on-site audit before certification. The duration of the internal audit should not exceed a day. It typically can be completed in four hours by an experienced auditor–plus a couple of hours of audit report writing.
Step 10: Conducting the CMDCAS Certification Audit
Your registrar conducts this step. Any audit findings will require a corrective action plan that is accepted by the auditor before the new certificate can be issued. The new CMDCAS certificate will look very similar to the existing certificate, but there is typically an additional logo indicating compliance with CMDCAS. This is not the same as the SCC logo indicating accreditation by the Standards Council of Canada. Once the initial extension to the scope is completed, the continued certification is evaluated as part of the normal surveillance audits and re-certification audits.
Step 11: License Application Submission
For a Class 2 device license application, you need to complete a form, send a check, and include a copy of your new ISO 13485 Certificate with CMDCAS. The response from Health Canada is typically within 15 days or less–depending upon the current workload. Class III and IV device license applications are more complex and require technical documentation–including a clinical evaluation.
The timelines for approval of a Class III or IV device license is closer to the timeline for a 510(k) clearance letter from the US FDA. Health Canada’s Device Licensing Division is quite responsive to email inquiries, and they will respond to voicemail messages. Once a license is issued, it is typically faxed to the company, and a hardcopy is mailed. I recommend a dedicated fax number for your regulatory affairs department.
Medical Device Academy, Inc. has a complete set of generic quality system procedures–including Canadian Medical Device Licensing and Mandatory Problem Reporting. Since the requirements for reporting adverse events is quite different in each country, it is not recommended to combine these procedures with other procedures. The cost of purchasing generic procedures from Medical Device Academy in a native MS Word Format is $300/procedure. Purchase grants your company a non-exclusive license to the content of the procedure for internal use. Please email Rob Packard if you are interested.