Recognizing that a global approach to assuring the safety of medical device manufacturing would provide tremendous benefit to the industry and the end user, the International Medical Device Regulators Forum (IMDRF) has created a harmonized approach to auditing and monitoring the manufacturing of medical devices. This new approach is designed with a goal of improving medical device safety as well as oversight of medical device manufacturing on an international scale. As a result, the Medical Device Single Audit Program or MDSAP was established.
The initial pilot phase of the MDSAP began in January 2014, with regulatory participants that include the United States Food and Drug Administration (FDA) alongside the Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, and Health Canada.
The MDSAP pilot enables medical device manufacturers to get an early start on having an authorized Auditing Organization (AO) under the MDSAP Pilot conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of those medical device regulatory authorities participating in the pilot program. As a result, MDSAP Pilot audit reports may be used by regulatory authorities participating in the MDSAP Pilot in lieu of their own inspection reports.
- US FDA – the FDA has confirmed that it will accept the MDSAP audit report as a substitute for routine Agency inspections (inspections conducted “For Cause” or “Compliance Follow-up” by FDA will not be affected by this program; the MDSAP program will not apply to any necessary pre-approval or post approval inspections for the Premarket Approval or PMA applications)
- Health Canada – has confirmed that it will operate the current Canadian Medical Device Conformity Assessment System (CMDCAS) program and the MDSAP in parallel during the three year pilot (from January 1, 2014 until December 31, 2016). During the Pilot, Health Canada will accept either an MDSAP certificate or a CMDCAS certificate for the purpose of obtaining a new (or maintaining an existing) Class II, III or IV medical device license, pursuant to section 32 of the Regulations. Upon successful completion of the pilot, Health Canada's intent is to implement MDSAP as the mechanism to achieve regulatory compliance for quality management system requirements in Canada.
- Brazil’s ANVISA – will utilize outcomes of MDSAP audit, including the reports, to constitute an important input on ANVISA’s pre-market and post-market assessment procedures, (providing, when applicable, key information that are expected to support the regulatory technical evaluation on these issues)
- TGA Australia - will use an MDSAP audit report as part of the evidence that is assessed with compliance with medical device market authorization requirements (unless the medical device is otherwise excluded or exempted from these requirements, or if current policy restricts the use of MDSAP audit reports)
- Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency
- The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers
The pilot phase for the MDSAP runs through the end of December 2016, and medical device manufacturers are encouraged to participate in the pilot in advance of full implementation of MDSAP in 2017.
What are the benefits?
The benefits of participating in the MDSAP pilot include:
- The ability to pilot the implementation of the requirements that are defined in the IMDRF MDSAP Model and provide feedback towards program improvement
- Getting an early start at minimizing the regulatory burdens on the medical device manufacturing industry
- The ability to reduce the amount of audits and inspections that a manufacturer must undergo as a result of a single audit standard being accepted by multiple regulatory agencies
- Advantages to leverage, where appropriate, existing requirements and procedures for conformity assessment.
- The ability to take advantage of cost and time savings from efficient and flexible use of medical device manufacturer’s resources
- The ability to expedite entrance in some markets where traditional regulatory oversight can cause significant inspection and audit delays
Benefiting from a consistency, predictability and transparency of regulatory programs by standardizing the practices and procedures of participating regulators.
Need help with MDSAP?
On December 4, 2015, Health Canada confirmed MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. This implementation will begin at the conclusion of the MDSAP Pilot on January 1, 2017, and will span a period of two years. During this two year period, Health Canada will accept certificates issued under both CMDCAS and MDSAP. As of January 1, 2019, only MDSAP certificates will be accepted.
Health Canada has pledged its commitment to work with the Standards Council of Canada, recognized third party auditing organizations ("Registrars") and medical device manufacturers to ensure the smooth operation of both programs during the pilot and the subsequent transition to MDSAP.
LR is engaged with the FDA, Health Canada, ANVISA and the TGA, and we’re working towards recognition as an MDSAP authorized Auditing Organization. We have trained MDSAP auditors and continue to expand our assessment resources in anticipation of increased MDSAP pilot project demand.
LR is also pledging to work closely with and support medical manufacturers that wish to get an early start and benefit from all advantages of the MDSAP and its available pilot, helping to ensure a smooth transition from CMDCAS for those that are currently CMDCAS certified and supporting new entrants to the program that may not have CMDCAS certification.
Why choose LR?
LR has established an in-depth knowledge and understanding of certification and CE mark approval within the medical devices sector. Our assessors are industry specialists and experts, enabling an effective and robust assessment of your system. Leading and emerging medical device manufacturers around the world choose LR because we offer:
- Dedicated Account Management, Client Focus and Proven Client Satisfaction – LR shares the same objectives as our clients - to help ensure safe and compliant products into the market as quickly as possible, thereby protecting consumers as well as the brands and reputations of our clients. LR medical device clients report a 92% satisfaction rating across key areas of our service.
- Accessibility to Technical Expertise – LR medical device experts are industry specialists who are available at any time and are only a phone call, text message or email away. Our medical assessors have some of the most extensive ISO 13485 and CMDCAS experience in the world. Many are hand-selected to provide input into the work of the ISO technical committees and are able to provide first-hand insight into requirements of the standard and the standard’s logic.
- Globally Recognized and Accredited – LR is recognized for our technical contributions to industry regulations and standards development. More than half of the world’s top 200 companies choose LR. LR is accredited by the Standards Council of Canada (SCC) and recognized by Health Canada to deliver accredited ISO 13485 and CDMCAS certification. Our CMDCAS experience and recognition make us an authorized Auditing Organization (AO) of choice for MDSAP.
- Impartiality and objectivity – With no shareholders of our own, we are independent and impartial in everything we do. We are committed to acting with integrity and objectivity at all times.
- Assessment methodology – helps you manage your systems and risks to improve and protect the current and future performance of your organization. Our approach is built on three pillars and extends the focus beyond the certificate to an assessment approach designed to help organizations meet their strategic objectives.
- Extended Range of Services – We offer you direct access to quality, environmental, safety, security, business continuity services and much more.
Demand for participation in the MDSAP pilot program continues to increase, and we encourage all medical device manufacturers interested in participating to contact LR now in preparation to get started.
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