Project Description

Medical Device Single Audit Program

Under the Medical Device Single Audit Program (MDSAP), the medical device manufacturers can let a recognized auditing body to conduct a single medical devices audit, for acceptance by the regulatory authorities of the participating countries. With the application of MDSAP, better alignment of regulatory approaches and technical requirements on medical devices can be expected in the future.

Participants

Currently, the participants for MDSAP include:

  • Food and Drug Administration (FDA) of USA
  • Health Canada (HC)
  • Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) of Japan
  • Therapeutic Goods Administration (TGA) of Australia
  • Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil

The Official Observers of the MDSAP include:

  • The World Health Organization (WHO)
  • Prequalification of In Vitro Diagnostics (IVDs) Program
  • Program and the European Union (EU)
How will MDSAP be used by Regulatory Bodies?

How the MDSAP will be used by the Regulatory Bodies?

  • FDA will accept MDSAP audit reports as a substitute for FDA routine inspections.
  • HC will ONLY accept MDSAP outcome as part of the CMDCAS certifiation program for Class II, III, IV medical device licenses from 2019, to prove compliance with regulatory QMS requirements.
  • TGA uses an MDSAP audit report as part of the evidence for compliance with medical device market authorization requirements, unless otherwise specified.
  • ANVISA utilizes the outcomes, including the reports, to constitute an important input on pre-market and post-market assessment procedures.
  • MHLW and PMDA will utilize the MDSAP audit reports in both pre-market and periodical post-market audits under the regulations.
Audit Requirements

A MDSAP audit can cover the requirements of:

  • ISO 13485:2003 / ISO 13485:2016 (Medical devices QMS Requirements for regulatory purpose)
  • Quality System Regulations (21 CFR Part 820) in USA
  • Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169) of Japan
  • Therapeutic Goods (Medical Devices) Regulations 2002 of Australia
  • Good Manufacturing Practices (RDC ANVISA 16/2013) of Brazil
  • Other specific requirements of participating regulatory authorities, such as requirements on medical device registration, technical documentation review, licensing, and adverse event reporting process.

Timeframe

After the launch on Jan 1, 2014, and following a 3-year pilot ending on Dec 31, 2016, the MDSAP started its operational phase form Jan 1, 2017.

Transition from CMDCAS to MDSAP

MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program. The period for transitioning from CMDCAS began from Jan 1, 2017. During the following 2-year transition period, the certificate under CMDCAS will be accepted by Health Canada until Jan 1, 2019.

MDSAP by DQS

DQS Med is one of recognized Audit Organizations for MDSAP. Besides the roles of certification body for ISO 13485:2016 certification and Notification Body for medical devices and CE marking, DQS can provide a MSDAP audit covering all applicable requirements of the participating regulatory authorities. The MDSAP will help your organization to reduce internal resource with lower audit cost for access to different markets.
Contact DQS-HK to answer any questions you have on MDSAP for medical devices.

Training by DQS

DQS Academy provides ISO 13485:2016 Internal Auditor Training and ISO 13485:2016 Lead Auditor Training courses, to help clients get the required knowledge for medical devices QMS implementation.