MDSAP Certification Service
Easily get Medical Device Single Audit Program (MDSAP) certification
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Fast & hassle-free MDSAP Certification
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Traditional audit processes require separate audits for each target market. However, medical device single audit program (MDSAP) streamlines the process. A single audit will fulfil the requirements of multiple regulatory authorities, namely U.S., Canada, Japan, Brazil, and Australia. We at Pharmadocx Consultants offer comprehensive MDSAP service to our clients.
What is Medical Device Single Audit Program (MDSAP)?
Medical device single audit program (MDSAP) is an international collaboration that allows medical device manufacturers to undergo a single audit to meet the regulatory requirements of multiple countries. This program streamlines the regulatory process, thereby reducing the need for separate audits by different regulatory bodies. It enhances global market access and builds regulatory trust. The international medical device regulators forum (IMDRF) oversees the MDSAP program. MDSAP evaluates the manufacturer’s quality management system against ISO 13485 as well as focusses on country-specific regulations. MDSAP certification helps medical device manufacturers efficiently achieve multinational compliance for their device.
Countries participating in the MDSAP program
The MDSAP certification is recognised by the regulatory authorities of the following countries:
- Canada:Health Canada
- United States:FDA (Food and Drug Administration)
- Brazil:ANVISA (National Health Surveillance Agency)
- Australia:TGA (Therapeutic Goods Administration)
- Japan: PMDA (Pharmaceuticals and Medical Devices Agency)/MHLW (Ministry of Health, Labour and Welfare of Japan)
MDSAP certification requires an audit by an MDSAP-recognized auditing organization. It will assess the QMS processes, risk management, and device safety practices. MDSAP audits will be logically and efficiently conducted in a consistent manner across auditing organisations. Moreover, it will focus on the interactions between processes. Additionally, it will flag any non-conformities in the system.
Is MDSAP Mandatory?
MDSAP is optional in Australia, Brazil, Japan, and the US. However, January 1st, 2019, onwards MDSAP is a mandatory requirement for class II, III, and IV medical devices in Canada.
5 Key Aspects of MDSAP
- Streamlined regulatory compliance process: MDSAP harmonizes the regulatory standards across participating jurisdictions. A single audit will cover multiple regulatory standards, saving time and resources.
- Enhanced Market Access: MDSAP certification will provide access to key international markets, such as U.S., Canada, Japan, Brazil, and Australia. It will help manufacturers reach a broader customer base globally.
- Regulatory compliance: MDSAP certification proves commitment to the highest standards of quality, safety, and regulatory compliance. By undergoing medical device single audit program, manufacturers will meet the stringent requirements of most regulatory authorities worldwide.
- Cost-effective approach: Instead of undergoing multiple audits across different jurisdictions, manufacturers can undergo a single audit. This will reduce audit-related expenses and resources can be allocated to other activities.
- Builds trust and improves credibility: The certification demonstrates a commitment to safety and quality as well as global regulatory compliance. It builds trust among patients and improves the credibility of the company among stakeholders.
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Medical Device Single Audit Program (MDSAP) Eligibility
- Manufacturers located anywhere in the world is eligible to participate.
- Any medical device manufacturer can participate, if the product falls under the scope of at least one participating regulatory authority. The product will be scrutinised per the quality management system requirements of the regulatory authority.
- Only the MDSAP participating countries have direct access to the audit reports.
- Manufacturers need to follow the audit approach.
- Manufacturers are required to have an effective quality management system (QMS) compliant with ISO 13485 guidelines.
How to Obtain Medical Device Single Audit Program (MDSAP) Certification? Step-by-step Guide
- Gap analysis: A comprehensive gap analysis to identify any areas of non-compliance with MDSAP requirements has to be performed. The existing quality management systems, procedures, and documentation have to be reviewed to ensure alignment with MDSAP guidelines.
- Staff training: Personnel should be trained and educated regarding the MDSAP requirements. Training programs should cover MDSAP requirements, audit procedures, and best practices for compliance. Knowledge and skills necessary to support the certification process should be imparted.
- Audit for MDSAP certification: Manufacturers can engage an accredited MDSAP auditing organization for performing the certification audit. During the audit, auditors will assess the manufacturer’s compliance with MDSAP requirements. The quality management system documentation, risk management, device labelling, and post-market surveillance strategies will be evaluated. Auditing organizations (AOs) are a third-party organization authorized to conduct MDSAP audits.
- Need for continuous improvement: MDSAP follows a three-year audit cycle, which includes an initial certification audit, two surveillance audits, and a re-audit (recertification audit). Hence, MDSAP is an ongoing commitment to quality and compliance. Thus, processes have to be in place for continuous improvement. Regular internal audits, management reviews, and corrective and preventive actions (CAPA) have to performed to maintain the certification.
Timeline to MDSAP Certification
The MDSAP certification process usually takes 3 to 6 months. However, the time required will vary depending on the organization’s preparedness.
What are the Benefits of MDSAP?
- International market access: MDSAP providers access to new markets globally. The certification will prove the manufacturers are in conformity with the standards of all participating countries’ guidelines.
- Minimized regulatory burden: A single MDSAP audit will reduce the regulatory burden on the manufacturer. MDSAP audit will require compliance with the highest degree of quality standards of all participating regulatory authorities. This will translate to complete regulatory compliance, better products, happy customers, thereby provide a more competitive edge.
- Simplified evaluation process: Manufacturers can perform a single audit that will satisfy the demands of several participating regulatory bodies. This will streamline the process and save time and money required for performing different audits for various regulatory agencies.
- Easily plan and efficiently manage regulatory activities: With MDSAP’s clear and predictable regulatory pathways, manufacturers may easily plan and efficiently manage their regulatory activities.
- Constant improvement: With MDSAP, the time and effort required to prepare for and go through several audits can be considerably reduced. Thus, manufacturers can reallocate the time and resources to R&D, product development, and improved customer support. This will foster an environment of continuous improvement.
- Improved risk assessment and early detection of problems: MDSAP focusses on a thorough evaluation of the manufacturer’s quality management system. This can assist in the early detection of possible issues and reduce the chances of non-compliance, thereby product recall can be avoided.
Our Medical Device Single Audit Program (MDSAP) Certification Service
- Consultation and Gap Analysis: We provide a detailed gap analysis of the manufacturer’s QMS against ISO 13485 guidelines and the country-specific regulations of MDSAP participating countries.
- Document Preparation: We provide comprehensive document preparation service.
- Mock Audit: We conduct mock audits to ensure preparedness. We train the manufacturer for the real MDSAP audit. Our mock audits will help identify areas of non-compliance and provide strategies for improvement.
- Risk Mitigation Support: We will help you identify potential compliance risks. This will enable manufacturers to avoid audit failures, product recalls, or market restrictions in MDSAP countries.
- Full Audit Support: We provide on-site and remote guidance during audits.
- Post-Audit Support: Our ongoing support ensures that your QMS is consistently MDSAP compliant. Additionally, we help manage any changes to products or processes that impact compliance. Furthermore, we implement corrective actions to mitigate issues.
Why should you partner with Pharmadocx Consultants?
- Expertise in US, Canada, Brazil, Japan, and Australia regulatory guidelines.
- We have in-depth knowledge of ISO 13485 guidelines.
- We customise our services per your requirements.
- Our time-efficient strategies will help you attain MDSAP compliance in a hassle-free manner.
- We provide compliance support even after certification is achieved.
To avail our comprehensive medical device single audit program (MDSAP) certification service, email at [email protected] or call/Whatsapp on 9996859227.
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