Medical device single audit program (MDSAP) is a global initiative designed to streamline the regulatory compliance process in participating countries. US, Canada, Brazil, Japan, and Australia are MDSAP members and participating countries of the program. We at Pharmadocx Consultants offer comprehensive MDSAP consultation service to our clients. We strive to help our clients achieve MDSAP certification with ease and gain access to international markets.
What is medical device single audit program (MDSAP)?
Medical device single audit program (MDSAP) is a single audit process to meet the regulatory requirements of multiple participating countries, namely the US, Canada, Japan, Brazil, and Australia. It reduces the number of audits required while ensuring compliance with each participating country’s laws, thereby saving time and costs. Notably, MDSAP is mandatory in Canada for Class II, III, and IV medical devices. However, it is optional in the other participating countries. Nevertheless, by opting for MDSAP you can have a streamlined regulatory journey in all the participating countries. International medical device regulators forum (IMDRF) has developed and oversees medical device single audit program (MDSAP).
This single audit ensures compliance of the QMS with ISO 13485 as well as country-specific regulations. Third-party auditors evaluate the manufacturer’s compliance using a single audit process. Hence, it is a globally recognized framework that simplifies regulatory audits for medical device manufacturers planning to launch their products in the MDSAP participating country. Availing an MDSAP consultation service can further ease out the MDSAP certification process for medical device manufacturers.
Key benefits of MDSAP
- Streamlined operations: Fewer audit inspections and predictable audit timelines will minimize production disruptions, thereby streamline operations.
- Single audit process: A single audit process will help meet regulatory expectations across major markets, namely USA, Canada, Brazil, Japan, and Australia.
- Cost-effectiveness: MDSAP helps reduce costs by consolidating multiple audits into a single audit. This will help reduce the cost associated with conducting multiple audits for different countries.
- ISO 13485 compliance: A single audit process will help attain full compliance with ISO 13485 guidelines and country-specific regulations.
- Resource optimization: By avoiding the costs associated with multiple audits, time and resources can be allocated to other activities.
- Transparency: Structured evaluations that are part of MDSAP will demonstrate compliance of your QMS and regulatory processes with globally accepted guidelines.
- Improved market access: MDSAP certification will ease out access to multiple global markets and ensure quick launch of these products in the market.
MDSAP participating countries
- Australia: Therapeutic Goods Administration of Australia (TGA)
- Brazil: Agência Nacional de Vigilância Sanitária (ANVISA)
- Canada: Health CANADA
- Japan: Japan’s Ministry of Health, Labour and Welfare (MHLW) and the Japanese Pharmaceuticals and Medical Devices Agency
- USA: Food and Drug Administration (FDA)
7 challenges in MDSAP Certification
- Extensive documentation requirements: Extensive and accurate documentation is needed for MDSAP.
- Complex regulatory requirements: Understanding and meeting the varying complex regulatory standards of participating countries can be laborious and cumbersome.
- Dynamic regulatory environment: Country-specific regulations within the MDSAP framework are constantly being updated and modified. It is difficult to stay abreast of the latest regulatory guidelines.
- Rigorous audit process: MDSAP audits are rigorous and comprehensive, covering both ISO 13485 and country-specific regulations. The audits require detailed preparation and robust quality management systems.
- Resource intensive: Implementing and maintaining MDSAP compliance requires significant resources, including time, finances, and skilled personnel.
- Audit readiness: MDSAP is rigorous and its audits process covers multiple aspects of the quality management system. Maintaining continuous audit readiness with respect to all aspects of the quality system is challenging.
- Limited approved auditors: Auditing organizations are in high demand. Hence, finding and scheduling audits with MDSAP-recognized auditing organizations (AO) is difficult.
Therefore, availing a MDSAP consultation service will help you easily overcome these roadblocks.
MDSAP consultation service: How can we help you easily achieve MDSAP certification?
We offer a structured and comprehensive MDSAP consultation service.
- Understanding your objectives: Our first step is to understand your organization’s goal and your aims with the MDSAP certification. Then, we offer a customized MDSAP consultation service proposal tailored to your company’s requirements.
- Planning and pre-audit: We thoroughly analyse your quality management system (QMS) process to identify potential gaps. Our pre-audit findings will help develop a detailed project plan and prepare your processes for audit readiness.
- Mock audit: Our MDSAP consultation service offers a mock audit service. We conduct thorough mock audits of your processes and systems to identify lapses in the system and provide mitigation strategies.
- Robust and effective QMS implementation: We assist in implementing effective and robust QMS to meet MDSAP and applicable global regulatory requirements. We assist in training your team on MDSAP compliance requirements. Additionally, our team will align your QMS with ISO 13485 guidelines and country-specific standards. Furthermore, we will help you prepare and compile the necessary documents required for MDSAP compliance.
- Guidance throughout the MDSAP audit process: Once your QMS and processes are at par with MDSAP standards, we will guide you through the official audit process. Upon successful audit and approval, your organization will receive the MDSAP certification. The MDSAP certification will open the gateway to all MDSAP participating countries, namely US, Canada, Brazil, Japan, and Australia.
- Post-audit compliance support: We offer comprehensive post-audit support to maintain continuous compliance.
For targeting global markets, securing the MDSAP certification is a crucial step for medical device manufacturers. Pharmadocx Consultants is a trusted consulting partner for medical device manufacturers planning to obtain MDSAP certification. We offer end-to-end MDSAP consultation service tailored to your company needs. Drop an email at [email protected] or call/Whatsapp on 9996859227 to avail our service.
FAQs
Who needs MDSAP certification?
Medical device manufacturers planning to launch their products in the US, Canada, Brazil, Japan, and Australia should obtain a MDSAP certification.
What is the scope of MDSAP?
The MDSAP evaluates compliance of your medical device with ISO 13485 guidelines and country-specific regulations for the participating countries.
Who conducts MDSAP audits?
MDSAP audits have to be conducted by recognized auditing organizations (AOs). Auditing organizations are accredited and authorized by the MDSAP participating regulatory authorities to conduct MDSAP audits.
Is MDSAP mandatory for medical devices?
MDSAP is a mandatory requirement for class II, III, and IV medical devices in Canada. Additionally, it will be beneficial for streamlining the regulatory process in other MDSAP participating countries, namely US, Brazil, Japan, and Australia.
What are the benefits of undergoing MDSAP?
MDSAP is beneficial for streamlining and simplifying the regulatory process. It reduces costs associated with multiple regulatory processes, minimizes redundant inspections, and improves global market access.
How to become eligible for an MDSAP audit?
Any medical device manufacturer planning to launch their product in one of the MDSAP member nations, namely US, Canada, Brazil, Japan, and Australia, will be eligible.
Is it possible for an MDSAP audit to certify CE marking?
MDSAP certification is not associated with CE marking certification for medical devices. European Union has an observer status in the medical device single audit program. Hence, it is not involved in the MDSAP’s implementation.
How do to find an Auditing Organization (AO) for MDSAP?
You can find recognized auditing organizations (AO) on the official websites of MDSAP regulatory members. Additionally, you can search on the MDSAP section of the IMDRF website. Furthermore, global certification bodies that comply with ISO/IEC 17021 guidelines are also authorized to conduct MDSAP audits.
How to demonstrate a successful MDSAP audit?
After the audit is completed successfully, the auditing organisation (AO) will provide a certification documentation linked to the MDSAP. This certificate will demonstrate compliance with ISO 13485 guidelines as well as the regulatory guidelines of each participating country.
Who can assist with MDSAP post-audit compliance?
We at Pharmadocx Consultants offer comprehensive post-audit support to address findings and maintain compliance.
How can Pharmadocx Consultants help with MDSAP compliance?
We provide comprehensive consultation and guidance, including gap analysis, regulatory documentation, mock audits, and staff training, for hassle-free MDSAP compliance. Avail our comprehensive MDSAP consultation service to easily secure the MDSAP certification.
