What is the MDSAP?
The Medical Device Single Audit Program (MDSAP) is a harmonised approach to auditing and monitoring the manufacturing of medical devices developed by the International Medical Device Regulators Forum (IMDRF). This global approach opens possibilities and pathways to support the development of a worldwide initiative of countries dedicated to pooling technology, resources, and services to improve the safety and oversight of medical devices on an international scale.
What is the MDSAP Pilot Program?
The initial pilot phase of the MDSAP, designed to confirm the proof-of-concept, was launched on 1 January 2014.
Participating Regulatory Authorities (RA) include the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), and the U.S. Food and Drug Administration (FDA). All RAs participating in the MDSAP Pilot are equal partners in the program.
The MDSAP Pilot enables medical device manufacturers to get an early start on having an authorised Auditing Organisation (AO) under the MDSAP Pilot conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the RAs participating in the pilot program.
As a result, MDSAP Pilot audit reports may be used by RAs participating in the MDSAP Pilot in lieu of their own inspection reports.
Who is the MDSAP Pilot for?
All medical device manufacturers that comply with the regulations of any of the RAs participating in the MDSAP Pilot are encouraged to undergo an audit under the MDSAP Pilot.
Manufacturers that participate in the MDSAP Pilot will be responsible for securing and maintaining a contract with an MDSAP recognised AO, and will pay for MDSAP audits conducted by an AO.
What benefits can manufacturers participating in the MDSAP Pilot enjoy?
- A single audit is used in lieu of multiple separate audits or inspections by participating RAs or their representatives. Therefore, for many medical device manufacturers, the MDSAP Pilot reduces the overall number of audits or inspections and optimises the time and resources expended on audit activities.
- Additionally, as a longer term goal, it is expected that the program will enhance confidence in the reliability of third party audits, that more RAs will join the program, and that other RAs will use information made available through the program to limit the need for additional audits.
- Some participating RAs will use MDSAP Pilot audit outcomes as an alternative to their own inspections to process applications for medical device marketing authorisation.
- The MDSAP Pilot is expected to improve the predictability of audit outcomes.
- Enrolling in the MDSAP Pilot may be seen as evidence of a medical device manufacturer’s commitment to quality management systems for product quality and regulatory compliance.
- Like in any third party auditing program, the medical device manufacturer is free to choose among all authorised AOs to perform the audits. Routine audits are announced and planned with the manufacturer.
Does the MDSAP Pilot add requirements for the manufacturer?
No. The MDSAP Pilot audit model was developed to cover existing requirements from the RAs participating in the MDSAP Pilot. The program does not add any new requirements to existing requirements from ISO 13485 or other country-specific requirements of the participating RAs.
How would manufacturers already holding ISO 13485 certification under the CMDCAS program transition to the MDSAP program? Will a full initial audit be required?
During the MDSAP Pilot, in order to minimise the impact on ongoing certifications under Canadian Medical Devices Conformity Assessment System (CMDCAS), the MDSAP audit cycle may be synchronised with the CMDCAS audit cycle.
Medical device manufacturers can participate in the MDSAP Pilot at their convenience and therefore their first MDSAP audit may be a surveillance audit.
LRQA as an MDSAP Authorised Auditing Organisation
LRQA is accredited by the Standards Council of Canada and recognised by Health Canada to deliver CMDCAS certification, and can ensure a smooth transition for organisations who wish to transition from CMDCAS to MDSAP prior to MDSAP being mandatory from 1 January 2019.
We are growing our team of trained MDSAP auditors, and are working towards recognition as an MDSAP authorised Auditing Organisation (AO).
Unlike other auditing organisations, LRQA’s unique assessment methodology takes your management systems from compliance to performance, in order to reduce business risk, and enhance the effectiveness, efficiency, and continuous improvement of your management systems.
To find out more about how LRQA can help you with your requirements, email us at firstname.lastname@example.org.