BSI Webinar: Critical update on Medical Device Single Audit Program (MDSAP): Countdown for Canada
16:00 PM - 17:00 PM
The Medical Device Single Audit Program (MDSAP) is an international initiative led by Regulatory Authorities (RA) to implement a program where Auditing Organizations (AO) can conduct a single audit of a medical device manufacturer that would be accepted by multiple regulators to address QMS/GMP requirements.
Health Canada has confirmed the requirement for medical device manufacturers to transition from CMDCAS to MDSAP to place devices into Canada. From January 1, 2019 Health Canada will only accept MDSAP for manufacturers who market their devices in Canada, hence, manufacturers will need to transition from ISO 13485 Certification issued by a CMDCAS recognized registrar to MDSAP Certification issued by an AO.
BSI is recognized AO and is already conducting MDSAP audits. This webinar will cover a summary of the Program, including what manufacturers can expect. However, this webinar will focus on the timelines and actions you need to take now to ensure continuity of supply for your products.
The four pillars set out by ABHI provide a foundation that underpins the prosperity of the medical technology industry in its role of supporting the NHS, and I look forward to working with ABHILord Phillip Hunt (Opposition front-bench spokesman on health, House of Lords )