The MDSAP offers medical device companies the opportunity to audit against a single set of conformance standards.
Participating regulatory bodies are the U.S., Japan, Australia, Brazil, EU, China and CAMCAS. Other countries are participating
in the program as observers and may require medical device companies to participate in the program in the future. For now,
Canada is the only country that by law currently requires companies to participate in the MDSAP. Specifically, all medical device
companies planning on selling their products in Canada beginning January 1, 2019, will be required to participate in the MDSAP
due to current ISO 13485 as the compliance and conformance document. It seems important to note that since MDSAP is almost
entirely based on ISO 13485:2016 (and compliance for that standard is due in March of 2019) companies that to work toward
meeting the ISO 13485:2016 and MDSAP standards in conjunction with one another will have the advantage of qualification for
all countries participating in the program. Only registrars currently used in Canada’s process can be qualified to perform such
audits.