Medical Device

Quality Tip MDSAP

MDSAP is an acronym for Medical Device Single Audit Program. Pilot companies who are manufacturers either selling into Canada or who have operations in Canada could volunteer to have a single based audit from a registrar authorized by the core MDSAP countries.  As a result, an audit is good for all regulatory bodies represented as well as the 13485-certification process to the 2016 version. If you are a company that wishes to have international presence for your product under a single audit the MDSAP program for registration would be the way to go.  As of 2017, this program helps organizations to singularly go to a state of readiness where they have each of the regulatory bodies — Canada, Australia, New Zealand, US, UK and Europe and Japan, where their regulations are either harmonized or there are unique conditions under which the audits are performed.  Now the program is active and the registrars who are qualified to perform the audits under strict circumstances can issue a certification to a single audit approved company.  The world is becoming smaller in the realm of Device/GMP compliance through this process. It is wise to consider the business case as ALL regulatory bodies get on board with this program and certification becomes the method of choice for compliance and conformance.

Leave a Reply

Your email address will not be published. Required fields are marked *