The intent of the Medical Devices Single Audit Program’s (MDSAP) is to allow manufacturers to meet the quality management system (QMS) for participating countries with a single QMS audit. The program was created by the International Medical Device Regulators Forum (IMDRF) and countries that are currently participating are: U.S. FDA, Health Canada, Australia Therapeutic Goods Administration (TGA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), and Brazil National Health Surveillance Agency (ANVISA), under the International Medical Device Regulators Forum (IMDRF).
The MDSAP three-year pilot commenced on January 1, 2014 and was replaced by the full-program launch on January 1st, 2017.
Health Canada CMDCAS move to MDSAP by 2019
In late 2015, Health Canada announced that it intended to implement MDSAP for quality management system requirements of the Canadian Medical Devices Regulations. MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program. The transition period of two years will end December 31, 2018, and after January 1, 2019, only MDSAP certificates will be accepted. During the transition, Health Canada will accept certificates issued under both MDSAP and CMDCAS.
FIGURE 1: Adoption of MDSAP and alternative if optional (Jan. 2017)
|Geography||Alternative to MDSAP||MDSAP||Audit Path In place of MDSAP||Formally Publicly Announced|
|USA-FDA||QSR 820||Optional||Directly by the FDA, per FDA schedule|
|Australia-TGA||CE Marking Path||Optional||By TGA|
|Brazil-ANVISA||ANVISA requirements||Optional||By ANVISA|
|Japan-PMDA||PAL||Optional||By PMDA or JPAL|
Similar to other management system audit programs, the MDSAP is based on a three-year audit cycle conducted in accordance with the requirements of ISO/IEC 17021:
- Stage 1 Initial certification Audit – Review of documentation and overall preparedness. Typically includes a review of the planning documentation.
- Stage 2 Initial certification Audit – Evaluate QMS compliance to ISO 13485, as well as other requirements of MDSAP-participating regulatory authorities.
- Surveillance audits – Surveillance audit is conducted annually to also assess any changes in the manufacturer’s products or QMS processes since the initial certification audit.
- Recertification audit – In the third year to evaluate a manufacturer’s QMS for its continued suitability and effectiveness in meeting QMS requirements under the MDSAP.
The MDSAP Benefits for Device Manufacturers
For the medical device industry, the IMDRF MDSAP is expected to significantly reduce the audit compliance challenges facing device manufacturers. Specific benefits of the MDSAP include:
- Harmonization of auditing requirements
- Broader acceptance of audit reports
- Reduced overall auditing time and expense
- Reduced time responding to findings
- Wider choice of 3rd party audit organizations
- More transparent and consistent oversight by regulators
UL utilizes in-house auditors so you have a consistent experience and benefit of years of expertise in the medical field.
UL medical quality system auditors have experience and educational backgrounds in medical devices, so you have less time “training” the auditor in the complexities of the medical industry.
UL auditors are located in the major medical markets around the world, reducing travel time and increasing the ability to communicate real time in the local language.
UL is an authorized Auditing Organizatio (AO) under the IMDRF’s MDSAP, and can provide medical device manufacturers with QMS pre- and post-market auditing services in all MDSAP jurisdictions.
Contact UL for more information: Medical.Inquiry@ul.com