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
Every country that participates in the MDSAP program has its own set of regulatory requirements established for the medical devices. It
is vital for manufacturers to meet all these requirements if they wish to market their product in the specific market.
Let’s look at the specific regulatory body responsible for approvals of medical devices in each country:
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.
Health Canada regulates medical devices in the Canadian market. Manufacturers must meet Canadian Medical Device Regulations to obtain market authorization.
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.
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.
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
In this phase auditor evaluate the quality and regulatory compliance by reviewing the organizational structure, management reviews, and oversight of outsourced activities
Auditors examine the manufacturer’s process for handling adverse events and advisory notices, ensuring timely reporting and appropriate actions
At this stage of MDSAP auditing, the auditor needs to assess the manufacturer’s design controls, including: design input, verification, validation, and design changes
The auditors evaluate the controls implemented by the manufacturer during production and post-production activities such as process validation, sterilization, and installation
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
MDSAP auditors at this phase of auditing assess the validation of processes critical to the safety and performance of the medical devices
The manufacturer’s risk management processes are scrutinized, including risk assessment, risk control, and risk communication at this phase by the auditor
The auditors at this phase are responsible to review the labelling and UDI implementation to ensure compliance with regulatory requirements
At this stage, auditors examine the manufacturer’s processes for ensuring the integrity and traceability of device packaging and distribution.
The manufacturer’s adherence to country-specific regulatory requirements is assessed during this phase by the MDSAP auditor.
Benefits of the MDSAP Audit Approach
Manufacturers no longer need to undergo separate audits for each country, saving time and resources.
Compliance with MDSAP requirements grants access to the markets of the five participating countries, facilitating international expansion.
Through thorough evaluations, the team ensures the quality of the QMS is upheld while identifying opportunities for improvement.
The MDSAP program is continuously improving to align with the demanding shift being introduced in the medical device regulatory frameworks. This is usually done by considering the feedback and experience from regulatory authorities and the industry, the program undergoes updates to improve its overall effectiveness.
The MDSAP program incorporates any new regulatory requirements or changes in the participating countries’ medical device regulations to maintain relevancy and alignment.
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.
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: In MDSAP, the whole idea is to help manufacturers allocate their resources efficiently by helping manufacturers concentrate on meeting the regulatory requirements of specific countries they wish to market their product in. This helps them save time and also reduce the cost involved.
Faster Market Entry: The whole approach of MDSAP is designed to save time and bring your products to market quickly. This ensures the faster market entry and also enables manufacturers to capitalize on the opportunities while generating revenue.
Considerations for Manufacturers
Future Expansion Plans: From manufacturers end, it is essential for one to consider their long-term expansion plans when you are deciding on your MDSAP approach. Initially, it might seem that it is enough to target one or two countries, but eventually in future the plans might change. This is why you should be considerate of this.
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:
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).
While MDSAP is for specific countries, ISO 13485 is an international standard that applies to all the markets.
ISO 13485 is a broader international standard applicable to all medical device manufacturers, regardless of the specific markets they intend to enter.
Audit Requirements:
The MDSAP audit requirements encompass the regulatory requirements of each participating country, making it more comprehensive and demanding.
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
Achieving MDSAP certification provides manufacturers with market access to the five participating countries, streamlining regulatory processes for international expansion.
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
One of the major thing common between MDSAP and ISO 13485 is that they both are design with the goal of helping manufacturers develop a robust QMS for your product.
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
MDSAP is usually considered a complex task as most manufacturers find it very confusing as regulatory requirements come from different countries.
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
Sharing experiences with one another about the best MDSAP practices can help you be more precise.
Utilizing Regulatory Experts
By contacting expert regulatory advisors or firms, you can easily simplify the complex regulatory process & prepare thorough audits.
Work with our team of experienced regulatory and quality consultants to navigate the challenges of the MDSAP audit effortlessl
Seek guidance from our team of expert regulatory an quality consultants to navigate the complexities of MDSAP audit with ease.
Conclusion
When it comes to the complex regulatory landscape of medical device, it can be challenging, but adopting the MDSAP framework provides a clear path for manufacturers aiming for global market access.
By understanding the core elements of the MDSAP audit process, keeping up with program updates, and addressing challenges early, manufacturers can meet international compliance requirements while upholding top-quality standards.
Regular improvement and innovative approaches enable manufacturers to succeed in the ever-changing 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.
