Last week StarFish Medical’s Registrar, Intertek, announced their application for recognition as an Auditing Organization (AO) under the Medical Device Single Audit Program (MDSAP). They hope to complete this process by the end of 2014.
For the program to be successful, it is essential that medical device companies volunteer to be audited to MDSAP requirements and to host witness audits.
The Medical Device Single Audit Program was developed by a group of medical device regulators to allow recognized third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2003 and their respective regulatory requirements. The benefit is that it would be recognized internationally. Please note that FDA, Health Canada, ANVISA and TGA participate while Japan opted to act as an observer, and China, EU and Russia are not participating in the program.
This is great news for medical device manufacturers as it will save thousands of dollars in Registrar’s fees, eliminate unnecessary duplication of inspections and allow faster access to markets in US, Canada, Brazil and Australia. However, it should be noted that this program is not replacing pre-market device applications.
To give you an example of implications of this change: one of our QMS in a Box clients recently obtained ISO 13485 certification. In order to apply for a medical device license in Canada they also require a CMDCAS inspection by the same Registrar. The additional CMDCAS requirements were in place at the time of the first audit but the Registrar needs to conduct another on site audit that will cost more than $5,000 plus the cost of the delay of selling the device in Canada. Very frustrating for all parties involved.
I recommend that you read more about the International Medical Device Regulators Forum (IMDRF) and MDSAP from the IMDRF website and from FDA’s website (check out Audit Model and Companion document). You can also request a consultation to discuss implications for your program and device.
Vesna Janic is a Director of Quality/Regulatory at StarFish Medical. She uses her expertise in regulatory compliance and conformance with standards to guide our QA/RA team and help clients avoid waste while gaining time to market.