Compliance specialist Maetrics has published a new guide in order to provide best practice guidance to medical device manufacturers and to help them navigate the new Medical Device Single Audit Program (MDSAP).
MDSAP is a global approach devised to audit and monitor the manufacturing of medical devices, with the objective of improving their safety and effectiveness. It is an international initiative led by Regulatory Authorities to implement a program in which a single audit of a medical device is accepted by multiple regulators to address QMS/GMP requirements.
With the stated objective to: “Develop, manage and oversee a single audit program that will allow a single regulatory audit to satisfy the needs of multiple jurisdictions,” the MDSAP will confirm and provide evidence of compliance with the ISO 13485 standard and the medical device regulations in Canada, Brazil, Japan, Australia and the USA.
Although the EU is currently just an observer, the success of the program suggests it may be extended to other geographies and has been such that Canada will actually enforce the MDSAP as mandatory in 2019.
In order to help manufacturers understand the MDSAP and how their businesses can harness it, Maetrics, has released a free guide and business analysis that can be downloaded here.
The practical whitepaper is divided in two main sections:
• an informative section, which focuses on an easy-to-understand analysis of the MDSAP including a stakeholder map, benefits from each jurisdiction, as well as a review of the MDSAP structure;
• a business analysis section, which provides a SWOT analysis and information to make strategic decisions.
Peter Rose, managing director, Europe at Maetrics, said: “The MDSAP is an exciting opportunity for medical device manufacturers and the industry to become more transparent and coordinated in its regulatory requirements, while at the same time providing the public with safer, better and more closely monitored products. Businesses wanting to launch products, or continue selling products in the five countries that have trailed MDSAP so far, would certainly do well to conform to retain competitivity.
“But even businesses that only sell to one of the five countries should consider that a single audit program is now able to make their products compliant with all five, effectively broadening their trade horizons. Finally, even where there are no existing commercial ties with these five countries, businesses would do well to familiarise with the process and understand its key principles as its success suggests that it may well be embraced elsewhere.”
