Who Needs an MDSAP Certificate?
Anyone looking to manufacture a Class II, III or IV medical device in Canada requires a Medical Device Licence (MDL) for each product they sell. In order to obtain an MDL you need an ISO 13485 certificate that has been issued through the Medical Device Single Audit Program (MDSAP). These certificates are evidence that your company has an appropriate quality management system in place to ensure that only safe and effective medical devices are made available for sale.
How do I obtain an MDSAP certificate?
First you must implement a quality management system within your company that meets the requirements of ISO 13485. The areas covered by these practices include design and development, production, storage and distribution, installation, and servicing of medical devices. Once all applicable procedures are in place you must contact an auditor that has been authorized to issue MDSAP certificates. Only certificates issued by approved auditors will be recognized by Health Canada.
Note that these certificates include a scope of the types of products that your company is authorized to manufacture. For example, if you obtain an MDSAP certificate for the manufacture of medical gloves you can get an MDL for medical gloves but not for home pregnancy tests. The scope of the certificate must match the type of product being sold. If you need to expand the scope of your certificate you must contact your auditor.
Why is it called a single audit program?
Historically every country would require their own audit of medical device manufacturer’s quality management system. This led to a situation where a company looking to sell in 5 different countries would often require 5 different audits of the quality management system. In order to reduce the burdens associated with multiple audits, several countries banded together to form the Medical Device Single Audit Program. Certificates issued through MDSAP will satisfy the audit requirements for all participating countries.
Countries that currently recognize MDSAP certificates include:
Are there any exemptions? What if I have an ISO 13485 certificate but it’s not MDSAP?
Health Canada won’t accept any other ISO 13485 certificate even if it’s from a major market such as the European Union. The only exception that has ever been granted is for devices related to the COVID-19 pandemic. Health Canada created a special approval pathway for these devices that would allow non-MDSAP certified companies to obtain authorization to sell their products.
I don’t have an MDSAP certificate and I’m not interested in obtaining one. What are my options?
The only option in this case is to enter into a private label agreement with a company that has one. The company you partner with must already have an MDSAP certificate and an MDL for the product they will be making. You will need to submit a Private Label Licence Application to Health Canada that states that your business partner will be conducting all manufacturing work and the product is identical to the already licenced product in every way except brand name and the company name listed on the label.