Inspections and Audits: Medical Devices
All facilities manufacturing, storing, testing, and importing products for human use are expected to operate in a way that ensures the products they handle are safe and of high quality.
Health Canada has the right to inspect Canadian facilities and manufacturers, distributors and importers may elect to conduct proactive or reactive internal audits to keep a pulse on the general status of the quality processes in the company or to correct quality concerns. Depending on the facility, inspections by Health Canada may occur on a cyclical schedule, without notice, or prior to issuing a license to operate. An internal audit or pre-licence inspection by NHP Consulting could be the difference between retaining/obtaining your license or losing/being refused your license after a Health Canada audit.
Our inspections can be customized to your needs, and we offer both on-site and remote (paper-based) audits. NHP Consulting will prepare an inspection audit report identifying key areas of concern and recommending a corrective action plan. We can conduct a facility audit for both existing clients and for companies who have not previously engaged us; for both, we provide an outside perspective on your facility readiness prior to a scheduled or unscheduled Health Canada assessment.
During an on-site pre-license inspection, one of our seasoned auditors will walk through your facility, noting the general facility layout and any deficiencies such as unsanitary conditions and possibilities for product contamination. After the facility is assessed, the NHP Consulting auditor will review all of your Standard Operating Procedures (SOPs) and recommend revisions to existing content to increase the efficiency and GMP compliance of your operation.
For some classes of products, audit observations appear in a public forum where both your customers and suppliers can see. Surprise audits by regulatory bodies are always a possibility and internal audits are the best strategy to identify and correct any aspects of non-compliance prior to a Health Canada Inspector entering your facility. A pre-audit inspection completed by NHP Consulting helps your staff know what to expect during the audit, and gives you an opportunity to correct any issues with the facility prior to Health Canada’s visit and any subsequent publication of negative results on the public database.
NHP Consulting offers audits in the following areas:
Medical Device Establishment Licence Inspection and ISO 13485 Preparedness Inspections
All manufacturers, distributors, and importers of medical devices are required to obtain a unique facility license (MDEL) for their business, and companies that hold or wish to apply for a MDEL may be subject to Health Canada audits. Some classes of MDEL are subject to regular, cyclical inspections by Health Canada. During an inspection, inspectors will review your organization’s systems and processes to verify conformance with a specific set of standards (e.g. ISO 13485, Medical Device Regulations, and GMP) and make observations of areas of non-compliance.
Corrective actions are generally required, with a written action plan addressing all observations to be provided to the inspector. As of 2017, all audit results for Medical Device Establishment License (MDEL) facilities are made public online, which means consumers and competitors of medical device companies can access any company’s audit results when evaluating contractual and purchasing decisions. The certainty of having negative results published makes it more important than ever to minimize observations of non-compliance during an audit.
As of March 1, 2019 all medical device facilities must demonstrate compliance with ISO13485:2016, which replaced ISO13485:2003. Further to the ISO13485 update, a new audit system (MDSAP – Medical Device Since Audit Program) is replacing CMDCAS around the same timeline. The MDSAP audit results will be submitted by the registrar to all regulatory bodies in the countries you market your product into. transition by reviewing your current quality system and identifying the changes required to come in line with ISO13485:2016.
Our team can prepare you for and host (or assist you in hosting) inspections by regulatory bodies, as well as manage post-audit communication and any corrective actions required.
Supplier, Foreign Site, and Critical Vendor Audits
Your organization may wish to audit a supplier or a foreign manufacturing site to confirm they meet regulatory requirements or when a quality issue is suspected or identified. There are also cases in which a supplier may hold a type of certification (e.g. ISO) required by one regulatory body, but requires an audit to confirm compliance with the standards required by another regulatory body (e.g. GMP). Likewise, critical vendors (ISO 13485), contractual agreements, and new supplier relationships can all prompt your organization’s need to audit another. Our consultants will ensure that your own organization’s needs are met, along with all applicable regulatory requirements. Drug Establishment Licence Inspection
Health Canada audits all applicants for Drug Establishment Licenses (DELs) prior to issuing this license, and a pre-inspection by one of our seasoned auditors allows you to correct any deficiencies in Good Manufacturing Practices (GMPs) prior to the audit, and we can also provide on-site support during Health Canada audits. If you already hold a DEL, Health Canada will have placed you on a cyclical audit plan.
Natural Health Product (NHP) Site Licence Inspection
In order to obtain and maintain a Natural Health Product site license for manufacturing, packaging, labelling, or importing natural health products (NHPs), applicants must attest to and provide proof of compliance with Good Manufacturing Practices (GMPs). Distributors and foreign manufacturers of NHPs are also expected to follow GMPs. NHP Consulting can audit your/your foreign suppliers’ existing facilities, procedures and records, or help you design and implement GMP-compliant procedures prior to applying for your site license.
Yearly proactive audit
Our team will customize the scope of your audit to the requirements of the facility you operate. Does the facility hold more than one type of license? Not a problem – we can audit you in parallel for various requirements (ISO, GMP etc.), saving you both time and money. Our audit reports can be presented to your applicable registrars of regulatory bodies during their cyclical audits as proof that your internal audit has been completed. You may choose to have us support you with follow-up activities indicated in the general section of this facility inspection page.
Reactive audits are those conducted in response to a specific quality concern identified by your staff, a consumer, or Health Canada. Our team will customize the scope of your audit to address the issue/concern at hand. Our audit reports can be used to correct the issues, and close open incidents. You may choose to have us support you with follow-up activities indicated in the general section of this facility inspection page.
Depending on your company structure and needs, you may only be looking for an audit specific to your quality processes. Our team will meet with you to customize the scope of your audit and tailor it to the quality processes.
Depending on your company structure and needs, you may only be looking for an audit specific to your regulatory processes (due diligence / government reporting / application filing etc.) Our team will meet with you to customize the scope of your audit and tailor it to the quality processes.
Training for on-site inspection
If you have the manpower, but not the experience, let us help you train your personnel so that you can manage your own internal audits. Our customized training takes into account both the experience of your staff as well as the scope of the audits you need to manage. We offer on-site training at your facility, which is a great team and confidence building experience, and saves cost by training the entire staff to avoid compliance issues.