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).

Timelines

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
Canada-HC None Required 01/2019 None Yes
Australia-TGA CE Marking Path Optional By TGA
Brazil-ANVISA ANVISA requirements Optional By ANVISA
Japan-PMDA PAL Optional By PMDA or JPAL

 

MDSAP Process

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

Why UL?

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

 

Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries.  This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers.  UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.  Read more about this.