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Medical Device Single Audit Program (MDSAP)

Medical Device Single Audit Program – TÜV Rheinland

Conform with multiple regulatory requirements with our MDSAP services

MDSAP is a single audit program that consists of one single regulatory audit of medical device quality management systems to meet relevant requirements of multiple regulatory authorities. Established by the International Medical Device Regulators Forum (IMDRF), the MDSAP supports a global auditing and monitoring approach for medical device manufacturing to assess the compliance of products used in the medical field.

As an authorized auditing organization, we offer the full range of necessary MDSAP audit services to assess if manufacturers meet the quality and regulatory criteria required by market regulators as well as the expectations of medical professionals and those under their care.

Our expert auditors perform efficient and effective assessments to provide you with the opportunity to gain the certification you need to satisfy the requirements of the following international regulatory authorities:

  • Australian Therapeutic Goods Administration (TGA)
  • The Brazilian National Health Surveillance Agency (ANVISA)
  • Health Canada (HC)
  • Japanese Ministry of Health, Labor and Welfare (MHLW) & Pharmaceuticals and Medical Devices Agency (PMDA)
  • United States Food and Drug Administration (FDA)

Contact us for more information about our MDSAP services!

MDSAP to demonstrate regulatory compliance and international market entry

Our comprehensive MDSAP auditing and certification services can give you a significant reduction in overall audit time needed to demonstrate compliance with multiple regulatory requirements through a single audit program. Many regulatory authorities may accept MDSAP results as an alternative to their own inspections when processing applications for medical device marketing authorization. Our program also combines the requirements of CE approvals with MDSAP thus further making compliance auditing as efficient as possible Reduce your corporate risk and protect your business with our recognized MDSAP audit and certification.

Our approach to MDSAP

MDSAP Audit Cycle | TÜV Rheinland
Our approach follows the three-step MDSAP audit cycle.

MDSAP has been put into place to develop, manage and oversee an independent audit program in which manufacturers of medical devices can present the results of a single regulatory audit to prove compliance and qualify for market entry in multiple countries and jurisdictions. MDSAP inspection of a manufacturer quality management system (QMS) must be conducted by an authorized auditing organization (AO). Our worldwide auditing resource is qualified under the MDSAP program

Our comprehensive MDSAP auditing services for medical device quality management systems follow a three-step audit cycle:

Initial certification audit - Stage 1
Review of key documentation, readiness and planning

Initial certification audit - Stage 2
Evaluate QMS compliance to ISO 13485 and all MDSAP regulation. Once the initial certification audit has been successfully completed, the MDSAP certificate will be issued, which will be valid for three years.

Surveillance audit
Annual audit to assess ongoing compliance, effectiveness of changes in products or QMS processes

Recertification audit
Every three years to determine manufacturer QMS suitability, effectiveness and compliance to MDSAP requirements

Manufacturers must be audited according to the scope declared in their applications for certification. Our experts determine which regulatory requirements apply to each manufacturer based on the countries in which medical device products are registered, sold or planned to be sold.

Applicable norms and standards:

  • ISO 13485:2003 or ISO 13485:2016
  • Australia
    Therapeutic Goods Administration Regulations
  • Brazil
    RDC ANVISA n. 16/2013 – Good Manufacturing Practice
    RDC ANVISA n. 23/2012
    RDC ANVISA n. 67/2009 – Vigilance
  • Canada*
    Medical Device Regulations SOR/98-282, Part 1

    * MDSAP auditing and a Canadian device license are mandatory for all manufacturers placing medical devise on the Canadian market, including companies with valid ISO 13485 under CMDCAS certification. All CMDCAS certificates must be transferred to the MDSAP program prior to December 2018.

  • Japan
    MHLW Ministerial Ordinance No. 169 (amended 2004 by MH
    Ordinance No. 128)
    2014 Articles 4 – 68 H
    Japan PMD Act

  • United States of America
    21 CFR Part 820 – Quality System Regulation
    21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 807 – Subparts A-D
    21 CFR Part 821 – Device Tracking (as applicable)

Your trusted one-stop-shop provider of MDSAP services

We provide comprehensive MDSAP services for manufacturers in the medical device industry. We are a Notified Body and Quality System Certification Body as well as an accredited testing house. Our service portfolio includes QMS auditing for suppliers and sales offices and comprehensive device testing services via our worldwide network of engineers and laboratory facilities. We can help you navigate complex market requirements with support in specific national testing needs and registration procedures. We are your innovative and ready partner for future digitalization applications in areas such as wireless, telemedicine and medical apps as well as cyber security - SG and personal data protection.

Learn how you can benefit from MDSAP auditing!

FAQ on MDSAP

Receive more information about our MDSAP services by reading our FAQ, which answers the following questions:

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Which version of ISO 13485 will be considered under the MDSAP program?

The transition period of ISO 13485 is honored by the MDSAP program. Until March 1st, 2019, quality management systems compliant to both ISO 13485:2003 and ISO 13485:2016 versions can participate.

After the transition, only ISO 13485:2016 based QMSs can be certified under MDSAP.

Is there any specific preparatory step to facilitate a successful MDSAP certification?

MDSAP is a conformity assessment program only, which should pose no new requirements. Therefore, the manufacturers currently distributing products to the markets of the participating countries should already be in compliance with the local regulations.

The Auditing Organization (AO) auditors will use the MDSAP audit model and companion document during the audit. Both of these can be a valuable tool during the preparation and can be downloaded from the FDA MDSAP website under MDSAP AU P0002.

For legal manufacturers currently to ISO 13485:2003 under CMDCAS, what is the process of transferring to MDSAP?

The MDSAP audit has to be performed as an initial certification performed in two stages.

  • Stage 1: 1 typical manday to evaluate the preparedness for the certification
  • Stage 2: 5-5.5 typical mandays on-site Stage 2 certification audit.

What is the earliest date from when clients can order MDSAP certification/audit?

2017-04-01. After this date, in 2017 and 2018, TÜV Rheinland will only offer CMDCAS audits as an exception (with certificate expiry date of Dec. 31st, 2018) to facilitate a timely transfer and meet Health Canada‘s transition plan. An earlier application is recommended to ensure a gapless transition.

Can the MDSAP initial certification audit be combined with audits to the other certifications?

Yes, typically the Stage 2 can be performed as part of a combined audit. However this might not always be practical, the overall audit scope and duration will need to be determined individually, and will likely be increased to allow time to evaluate compliance to other requirements (e.g. EC-Directives).

To have the combined audit at the usual date, it is recommended to request the Stage 1 a month earlier than usual. An MDSAP certification audit resulting in negative recommendation does not necessarily jeopardize the other certifications (unless the nonconformity applies generally to other requirements as well).

What is TÜV Rheinland’s current status as AO?

As of January 1st, 2017, we are an authorized AO under the MDSAP program. The current status can be confirmed here.

More information about our MDSAP services

pdf FAQ – MDSAP 260 KB Download

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