In the rapidly evolving landscape of medical device regulations, ensuring compliance with various international standards has become a significant challenge for medical device manufacturers.
The Medical Device Single Audit Program (MDSAP) has turned out to be a global solution to address this complexity by harmonizing and streamlining regulatory audits across multiple countries.
This article aims to provide valuable insights and recommendations to medical device manufacturers, shedding light on the MDSAP process and its benefits in achieving global market access while maintaining compliance.
What is MDSAP?
Understanding the MDSAP Program
The Medical Device Single Audit Program (MDSAP) is a unique initiative jointly developed by regulatory authorities from five major countries –
- United States
- Canada
- Brazil
- Japan
- Australia
The program was designed to streamline the audit process for medical device manufacturers by establishing a single, unified approach to auditing and monitoring their quality management systems.
MDSAP Country-Specific Requirements
Each participating country within the MDSAP program has its own specific regulatory requirements and guidelines for medical devices.
Comprehending and adhering to these requirements is crucial for manufacturers seeking to gain access to the respective markets.
Let’s explore the specific regulatory body responsible for approvals of medical device of each country:
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United States (FDA)
The Food and Drug Administration (FDA) of the United States regulates medical devices within the country. Manufacturers must adhere to the FDA’s strict regulations and quality standards to gain market approval.
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Canada (Health Canada)
Health Canada regulates medical devices in the Canadian market. Manufacturers must meet Canadian Medical Device Regulations to obtain market authorization.
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Brazil (ANVISA)
The Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), oversees medical device regulation in Brazil. Compliance with ANVISA’s requirements is essential for market entry.
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Japan (MHLW and PMDA)
Japan’s medical device regulatory system is managed by the Ministry of Health, Labour, and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). Manufacturers must navigate Japan’s stringent regulatory process to enter the Japanese market.
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Australia (TGA)
The Therapeutic Goods Administration (TGA) is Australia’s regulatory body for medical devices. Manufacturers must meet TGA’s requirements to gain access to the Australian market.
Why was MDSAP developed?
A Unified Approach to Global Auditing
The need for a more effective and streamlined auditing process led to the development of MDSAP. With medical devices crossing borders more frequently, it became evident that a harmonized approach to audits was necessary to eliminate redundant assessments and promote international consistency.
Collaboration between Regulatory Authorities
The development of MDSAP resulted from the collaboration between regulatory authorities from the United States, Canada, Brazil, Japan, and Australia.
By working together, these countries sought to create a standardized audit program that would allow medical device manufacturers to gain access to multiple markets through a single audit.
MDSAP Audit Approach
The MDSAP audit approach is a comprehensive and systematic evaluation of the quality management system of a medical device manufacturer. It focuses on key areas such as management responsibility, design controls, corrective and preventive actions, risk management, and labelling, ensuring that the manufacturer meets the regulatory requirements of each participating country.
MDSAP Audit Sequence
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Management Responsibility
In this phase auditor evaluate the quality and regulatory compliance by reviewing the organizational structure, management reviews, and oversight of outsourced activities
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Medical Device Adverse Events and Advisory Notices
Auditors examine the manufacturer’s process for handling adverse events and advisory notices, ensuring timely reporting and appropriate actions
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Design and Development
At this stage of MDSAP auditing, the auditor needs to assess the manufacturer’s design controls, including: design input, verification, validation, and design changes
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Production and Service Controls
The auditors evaluate the controls implemented by the manufacturer during production and post-production activities such as process validation, sterilization, and installation
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Corrective and Preventive Actions
At this phase, the MDSAP auditor needs to examine the manufacturer’s approach to addressing non-conformities that are mostly carried out by analyzing the root causes, and incorporating effective corrective and preventive actions
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Process Validation
MDSAP auditors at this phase of auditing assess the validation of processes critical to the safety and performance of the medical devices
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Risk Management
The manufacturer’s risk management processes are scrutinized, including risk assessment, risk control, and risk communication at this phase by the auditor
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Labelling and Unique Device Identification (UDI)
The auditors at this phase are responsible to review the labelling and UDI implementation to ensure compliance with regulatory requirements
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Packaging and Distribution
At this stage, auditors examine the manufacturer’s processes for ensuring the integrity and traceability of device packaging and distribution.
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Regulatory Compliance
The manufacturer’s adherence to country-specific regulatory requirements is assessed during this phase by the MDSAP auditor.
Benefits of the MDSAP Audit Approach
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Reduced Redundancy
Manufacturers no longer need to undergo separate audits for each country, saving time and resources.
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Market Access
Compliance with MDSAP requirements grants access to the markets of the five participating countries, facilitating international expansion.
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Enhanced Quality Systems
Through rigorous evaluation, manufacturers are encouraged to maintain and improve their quality management systems.
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Continuous Improvement of the MDSAP program
The MDSAP program is dynamic and regularly updated to align with the ever-changing landscape of medical device regulations. As regulatory authorities and industries gain experience and feedback, the program undergoes improvements to enhance its effectiveness.
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New Regulatory Requirements
The MDSAP program incorporates any new regulatory requirements or changes in the participating countries’ medical device regulations to maintain relevancy and alignment.
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Improved Audit Processes
Feedback from manufacturers and regulatory authorities helps to enhance the efficiency and clarity of the MDSAP audit processes, making them more effective and focused on patient safety.
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Alignment with International Standards
MDSAP audit criteria are continuously harmonized with relevant international standards, such as ISO 13485, to ensure a comprehensive assessment of quality management systems.
Recent Upgrades to MDSAP Audit Approach
Audits conducted within the MDSAP strictly adhere to a prescribed process, comprising defined tasks that auditors must perform. The MDSAP Audit Approach (MDSAP AU P0002) outlines the audit tasks and provides links to applicable regulatory requirements for participating countries. The document has undergone its latest update in March 2023, now being revised to version 008.
The revised version incorporates changes listed in a summary of modifications from the previous version. Among these changes, the most significant is the introduction of an option to modify the sequence in which processes are audited.
While the MDSAP audit approach traditionally follows a set sequence as listed above. However, the new update allows the audit of the Production and Service Controls process to take place after the completion of the Measurement, Analysis, and Improvement, and then the Design and Development processes. This adjustment is deemed an acceptable deviation from the MDSAP audit sequence.
Focus on specific requirements for Canada and Australia:
For Canada, clarifications have been made regarding the auditing of private-labelled medical devices, assessment of design changes resulting from corrective or preventive action, and references to Canadian guidance documents.
For Australia, changes include corrections to hyperlinks, adjustments to design and development process requirements, and revisions related to product preservation in extreme temperature conditions.
As organizations participate in the MDSAP, it is essential to take note of these changes and assess their potential impact on their preparation for initial or surveillance audits under the program
The revised version incorporates changes listed in a summary of modifications from the previous version. Among these changes, the most significant is the introduction of an option to modify the sequence in which processes are audited.
While the MDSAP audit approach traditionally follows a set sequence as listed above. However, the new update allows the audit of the Production and Service Controls process to take place after the completion of the Measurement, Analysis, and Improvement, and then the Design and Development processes. This adjustment is deemed an acceptable deviation from the MDSAP audit sequence.
A Focused Approach for Select Countries
While MDSAP typically involves five participating countries (the United States, Canada, Brazil, Japan, and Australia), manufacturers have the option to focus on only two to three countries, tailoring the audit to their specific market expansion needs.
Understanding MDSAP for Two to Three Countries
Tailoring the MDSAP Program: The MDSAP program is flexible enough to accommodate manufacturers who wish to pursue certification for only two to three participating countries instead of all five.
This focused approach allows manufacturers to prioritize their target markets based on strategic considerations, market potential, and regulatory requirements.
Choosing the Participating Countries: Manufacturers can select the countries that align best with their business objectives and expansion plans. For example, a medical device company may choose to focus on the United States and Canada initially to gain access to two significant and neighbouring markets, and only later
MDSAP Audit Process for Selected Countries
Audit Criteria and Scope: When a manufacturer chooses a focused approach with two to three countries, the MDSAP audit process concentrates on the specific regulatory requirements of the selected countries.
The audit criteria and scope are tailored to meet the needs of these specific markets, ensuring compliance with the relevant regulations and quality standards.
Selecting Qualified Auditors: The participating countries in the focused approach have their own authorized auditing organizations. These auditors will assess the manufacturer’s quality management system against the regulatory requirements of the selected countries.
Benefits of a Focused MDSAP Approach
Efficient Use of Resources: Opting for a focused MDSAP approach enables manufacturers to allocate their resources more efficiently. By targeting specific countries, manufacturers can concentrate their efforts on meeting the unique regulatory requirements of those markets, saving time and costs compared to pursuing all five countries simultaneously.
Faster Market Entry: By streamlining the audit process for select countries, manufacturers can achieve MDSAP certification more quickly. This faster market entry allows manufacturers to start distributing their medical devices in the chosen markets sooner, capitalizing on opportunities and generating revenue.
Considerations for Manufacturers
Future Expansion Plans: Manufacturers should carefully consider their long-term expansion plans when choosing a focused MDSAP approach. While focusing on two to three countries may be suitable initially, future plans to enter additional markets may warrant a broader MDSAP certification.
Regulatory Updates: Regulatory requirements in the chosen countries may change over time. Manufacturers must stay updated with any changes in regulations and adapt their quality management systems accordingly to maintain compliance.
Difference between MDSAP and ISO 13485
Scope of Application:
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MDSAP
The MDSAP program is primarily designed for medical device manufacturers seeking to gain access to the markets of the five participating countries (United States, Canada, Brazil, Japan, and Australia).
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ISO 13485
ISO 13485 is a broader international standard applicable to all medical device manufacturers, regardless of the specific markets they intend to enter.
ISO 13485 is a broader international standard applicable to all medical device manufacturers, regardless of the specific markets they intend to enter.
Audit Requirements:
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MDSAP
The MDSAP audit requirements encompass the regulatory requirements of each participating country, making it more comprehensive and demanding.
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ISO 13485
ISO 13485: While ISO 13485 audits are significant in their own right, they are generally more focused on assessing compliance with the standard’s specific requirements.
Recognition and Market Access
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MDSAP
Achieving MDSAP certification provides manufacturers with market access to the five participating countries, streamlining regulatory processes for international expansion.
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ISO 13485
ISO 13485 certification is recognized globally and can support market access in various countries, but it may not directly replace individual country-specific regulatory requirements.
Similarities between MDSAP and ISO 13485
Quality Management System Focus
Both MDSAP and ISO 13485 are centred around establishing and maintaining a robust quality management system that ensures consistent product quality and safety.
Risk Management
Both standards emphasize the importance of risk management in the medical device industry, requiring manufacturers to identify, assess, and mitigate risks associated with their products.
Continuous Improvement
Both MDSAP and ISO 13485 promote a culture of continuous improvement, encouraging manufacturers to monitor their processes, identify areas for enhancement, and implement corrective actions when necessary.
Challenges Faced by Manufacturers in MDSAP Implementation
Complex Regulatory Requirements
Manufacturers often struggle to navigate the intricate web of regulatory requirements from multiple countries, making MDSAP implementation a daunting task.
Resource Constraints
MDSAP preparation and execution demand significant resources, posing challenges for smaller manufacturers with limited budgets and personnel.
Time Constraints
The need to meet MDSAP deadlines while continuing day-to-day operations can lead to time management issues for manufacturers.
Recommendations for Successful MDSAP Implementation
Robust Training and Education
Investing in comprehensive training programs for employees can help manufacturers stay updated with evolving regulatory requirements and quality standards.
Collaboration and Knowledge Sharing
Manufacturers can benefit from sharing experiences and best practices with industry peers who have already undergone MDSAP audits.
Utilizing Regulatory Experts
Seeking guidance from regulatory consulting firms or hiring regulatory experts can alleviate the burden of interpreting complex regulations and preparing for audits.
Seek guidance from our team of expert regulatory an quality consultants to navigate the complexities of MDSAP audit with ease.
Need Assistance With MDSAP?
Our Experts will help you find the right path to MDSAP without any delays and compliance issues. All you have to do is contact us.
Contact UsConclusion
Navigating the evolving landscape of medical device regulations can be challenging, but embracing the MDSAP framework offers a viable solution for manufacturers seeking global market access.
By understanding the key components of the MDSAP audit process, staying updated with recent program updates, and addressing associated challenges proactively, medical device manufacturers can ensure compliance with international standards while maintaining the highest quality standards.
Embracing continuous improvement and adopting innovative solutions will empower manufacturers to thrive in the dynamic and competitive medical device industry.
Our experienced professionals can help alleviate the burden of interpreting complex regulations, ensuring a smooth and successful MDSAP audit process for your medical device manufacturing company. Contact us today to unlock the path to regulatory compliance and global market access!
FAQs
The MDSAP audit scope includes key areas such as management responsibility, design controls, corrective and preventive actions, risk management, and labelling. It evaluates compliance with the regulatory requirements of each participating country.
The frequency of MDSAP audits may vary based on the risk classification of the medical devices and the regulatory requirements of the participating countries. Manufacturers must ensure compliance with the required audit intervals.
Yes, the MDSAP program is widely recognized and accepted as an efficient and comprehensive approach to auditing medical device manufacturers. It allows manufacturers to gain market access to multiple countries through a single audit.
Yes, manufacturers have the flexibility to add or remove countries from the MDSAP audit process based on their business needs and expansion plans.
No, participation in the MDSAP program is not mandatory for all medical device manufacturers.
Elexes Team
Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.
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