The Medical Device Single Audit Program (MDSAP) provides medical device manufacturers an option for a single audit that satisfy the regulatory requirements of five participating countries (Australia, Brazil, Canada, Japan, USA), and allows medical device companies to market in these countries.
By successfully getting audited in this comprehensive audit program, you, as a medical device organization, not only target multiple new markets but also minimize business disruptions that can happen with different regulatory audits.
In this article, we will take a close look at the MDSAP, its purpose, benefits, the participating regulatory authorities, and the typical audit process.
We will also give relevant examples of how a modern Electronic Quality Management System (eQMS) can help your company prepare for the MDSAP.
One way to better prepare for the MDSAP is to have a modern eQMS in place. SimplerQMS provides QMS software for medical device companies that helps better manage quality management processes, make compliance easier, and reduce disruption in workflows. To learn more about how SimplerQMS can help your organization feel free to book a demo and talk to one of our Quality Solution experts.
Go directly to the sections that you want to learn more about first:
- What is Medical Device Single Audit Program (MDSAP)?
- What is the Purpose of MDSAP?
- What are the Benefits of the Medical Device Single Audit Program?
- Which Regulatory Authorities are Participating in MDSAP?
- MDSAP Audit Cycle
- Medical Device Single Audit Program (MDSAP) Audit Process
- MDSAP: Key Considerations
- Frequently Asked Questions About MDSAP
- The Role of QMS Software in Preparation for MDSAP
What is Medical Device Single Audit Program (MDSAP)?
MDSAP stands for Medical Device Single Audit Program. It is a unique program that allows your company to face a single, third-party audit and satisfy multiple international regulatory requirements and standards.
With MDSAP, you only have to face a single audit for compliance with the regulatory requirements of 5 medical device markets, namely, Australia, Brazil, Canada, Japan, and the United States.
What is the Purpose of MDSAP?
The purpose of the medical device single audit program is to have a more unified global approach to the auditing and monitoring of medical device manufacturers.
The main benefits that you get by participating in MDSAP are access to multiple international markets (currently 5 countries are participants in MDSAP). As well as, common international supervision of the safety and efficacy of your finished products, and increased brand value.
For instance, your medical device company has invented a robotic, ocular-free, the 3-dimensional microscope for reconstructive surgery. The uniqueness of your invention is that the ocular-free design will allow surgeons a highly personalized view while they are doing reconstructive procedures.
After its successful launch and marketing in the European Union, where you are based, you now want to target multiple international markets. By complying with the requirements of MDSAP, you hit five birds with one stone, so to say. You gain access to 5 major international markets.
What are the Benefits of the Medical Device Single Audit Program?
To further elaborate on the benefits of MDSAP, let’s take a deeper look at what are the benefits for medical device manufacturers, patients, and regulators.
Benefits for medical device manufacturers:
- Single comprehensive audit: Your medical device company will face a single audit program and not numerous individual audits. By participating in MDSAP you will minimize business disruptions, and save precious resources (time, finances, training).
- Commitment to quality: When you are successfully audited in MDSAP, you will emphasize to your stakeholders (regulatory agencies, customers) your commitment to quality and compliance with an international regulatory standard.
- Anticipated audit schedules: The MDSAP has a well-laid out schedule with a three-year time frame. Keeping this in mind, you will be well-prepared with your time frames and resources.
Benefits for patients and end-users:
- Patient safety: How are patients and end-users of medical devices assured of the safety and efficacy of these products? By successfully getting audited according to MDSAP, you are assuring patients and end-users that all your medical devices are safe, efficacious, and intended for their pre-defined use.
Benefits for regulatory agencies:
- Satisfied needs of multiple regulatory agencies: Since the MDSAP audit program is conducted by authorized Auditing Organizations (AOs), the participating regulatory agencies are assured that auditing has been done in accordance with the rules laid down. This lessens much of the work that participating agencies have to do.
Which Regulatory Authorities are Participating in MDSAP?
The MDSAP auditing program is under the purview of the International Medical Device Regulators Forum (IMDRF).
There are currently 5 international regulatory agencies that are participants in MDSAP:
- Therapeutic Goods Administration of Australia
- National Health Surveillance Agency of Brazil (Anvisa)
- Health Canada
- Ministry of Health, Labour and Welfare of Japan, and Japanese Pharmaceuticals and Medical Devices Agency
- U.S. Food and Drug Administration
Therapeutic Goods Administration of Australia
According to the Australian Therapeutic Goods Administration (TGA), your MDSAP certificate is on par with your CE certification. Therefore, medical device companies that have successfully passed the MDSAP audit are deemed to satisfy the requirements.
National Health Surveillance Agency of Brazil
Brazil’s Anvisa (National Health Surveillance Agency) uses MDSAP audit reports as part of its initial auditing procedures.
For all higher-risk devices, ANVISA continues to use its regular audits and inspections.
Health Canada has started accepting MDSAP compliance audits in their entirety from the beginning of January 2019.
This means that your medical device company does not have to face any additional audits in Canada.
Japanese Regulatory Authorities
The Japanese Regulatory Authorities (Ministry of Health, Labour and Welfare of Japan, and Japanese Pharmaceuticals and Medical Devices Agency) have completely adopted the MDSAP program.
Thus, Japanese QMS (J-QMS) audits are no longer needed for medical companies targeting the Japanese market.
U.S. Food and Drug Administration
The US FDA will accept MDSAP audits in place of routine inspections (which are biennial).
However, you should note that the FDA still conducts initial visits and ‘for cause’ inspections.
MDSAP Audit Cycle
The complete MDSAP has a three-year audit cycle consisting of:
- An Initial Audit (the Initial Certification Audit)
- Partial Surveillance Audits in years 2, 3
- Complete Re-Audit in year 3
This audit model will review whether your company’s QMS is compliant in accordance with ISO 13485:2016. As well as, the individual regulatory requirements of the participating countries, where you wish to market your finished devices.
The initial audit will comprehensively audit your Medical Device Quality Management System.
It consists of Stage 1 and Stage 2 Audits.
The purpose of the stage 1 audit is complete a QMS documentation review and to evaluate whether you are ready to go to the next stage audit – the stage 2 audit.
The purpose of the stage 2 audit is to make sure that your company’s QMS has been effectively implemented in accordance with ISO 13485 and the requirements of the participating regulatory agencies.
The Re–audit (the Recertification audit) can include a Stage 1 audit if your QMS has undergone a critical change that was not sufficiently assessed previously.
In addition to these audits, you can face Special Audits conducted by individual regulatory agencies.
Another important audit that you are likely to face is an Unannounced Audit. This audit can be conducted anytime during the three-year audit cycle. During this audit, the regulatory agency will randomly select a representative product (or more than one) and check whether it has been manufactured in accordance with your company’s QMS.
Medical Device Single Audit Program (MDSAP) Audit Process
Now we will take a deeper look at the MDSAP audit process.
We will also give examples of how an Electronic Quality Management System (eQMS), like SimplerQMS, can help your company successfully prepare for the MDSAP.
This article does not explain all the details related to MDSAP, only the key aspects. Do follow the official standards and requirements that apply to your organization. Complete and the latest details are provided on official websites such as the FDA – MDSAP Audit Procedures and Forms.
As stated before, the International Medical Device Regulators Forum (IMDRF) has recognized third-party auditors to conduct the MDSAP for medical device companies.
For instance, the FDA has a list of recognized auditing organizations (MDSAP AOs) – see “Auditing Organizations”.
Do note that the initial or recertification audit of your Quality Management System (QMS) will include a complete evaluation of the control of the sterility of all sterile medical devices that you manufacture.
The surveillance audits are usually restricted to the verification of certain aspects of the QMS. These are the execution of validated process parameters, control and monitoring activities, and final product release.
Another key aspect of MDSAP is that only a few auditing activities are remotely done.
For instance, the inspectors can review your sterilization process validation reports off-site. Such off-site audits are added as inputs to the actual on-site audit, and the details are attached to the final MDSAP audit report.
Feel free to check out our article on remote audit best practices to learn more about this topic.
Once you have successfully completed the initial audit/re-audit, the MDSAP AO (MDSAP Auditing Organization) will give your company the necessary certification documents. These will state your compliance with ISO 13485 and the individual regulations of the participating agencies.
MDSAP audits are conducted in a logical and focused manner by Authorized Organizations (AOs).
Four primary processes, one enabling process, and two supporting processes are part of the audit.
- Measurement, Analysis, and Improvement
- Design and Development
- Production and Service Controls
- Device Marketing Authorization and Facility Registration
- Medical Device Adverse Events and Advisory Notices Reporting
The two supporting processes will fulfill the regulatory requirements of the participating jurisdictions.
The auditors will start with the Management Process and then proceed to the second primary process, and so on.
Each of the seven processes is further subdivided into “Tasks”, namely, specific instructions for the auditing team. These tasks include specific clauses from ISO 13485:2016 and regulatory requirements of the participating nations.
The top management of your medical device company must ensure that:
- Sufficient resources are provided for device design and manufacturing
- The quality management system is proper and effective
- Monitor the QMS and make adjustments when needed
- Define, document, implement, and maintain the QMS requirements via a representative
How will you guarantee that your products are safe and efficacious if top management is not seen to be serious about quality?
It is essential that top management show commitment to quality.
Also, this demonstrated quality commitment must be communicated to everybody concerned. This will assure employees and third-party stakeholders such as the regulatory agencies and end-users that your finished products are safe, efficacious, and for their intended purpose only.
The quality data that the top management obtains from different sources within and outside the organization must be analyzed to get a single source of truth.
With this information, you can gauge your preparedness for the audit, make changes if required, provide additional resources, and so on.
Collating data into a single source of truth is much easier using an eQMS system paired with powerful document controls such as SimplerQMS. It allows you to gather data from all the departments and processes and brings them into a centralized cloud-based repository.
Documents and their associated information can be linked together, automatically named, versioned, and retrieved during the audits with ease.
No more hunting and running about searching for files or documents when needed. Just log in to the system, search for the documents you need, and get them in no time.
Measurement, Analysis, and Improvement Process
The second primary process that you will be audited for is the Measurement, Analysis, and Improvement Process.
MDSAP highlights your company’s planning and implementation for measuring, monitoring, analyzing, and improvement of essential processes and protocols for conforming products and QMS, and the effectiveness of your QMS.
You will need to identify any nonconformity and determine whether corrective and preventive action (CAPA) is needed. When CAPAs are initiated, they must be documented.
Further, has an investigation been launched? If not, reasons are provided.
All outcomes must be documented and informed to the regulatory agency.
You will understand that these quality processes, including documenting nonconformances, complaints, and CAPAs are time-sensitive matters that need to be quickly and efficiently documented.
QMS software solution like SimplerQMS allows you to keep track of all nonconformities, complaint resolution progress, CAPA status, and so on. With such a system you can easily provide the regulatory agencies with the required data with just a few clicks.
Design and Development Process
The purpose of the Design and Development Process is to ensure that all steps in the lifecycle of a medical device are according to defined protocols and processes.
The key steps that you are expected to follow here are:
- Design and development planning: Have updated and approved plans for all medical devices that you manufacture.
- Design input: Design input means that the protocols are in place so that the initial design for a given medical device must corroborate with its actual use. If there is ambiguity or incompleteness in a design, it must be looked into.
- Design output: With proper design output protocols, the design output of every medical device will conform to the original design input.
- Design review: Key personnel involved in the design of a particular device need to monitor and conduct formal (and documented) reviews at selected intervals. Design review will also involve other individuals who do not have direct responsibility, and specialists, if needed. Document the results in the Design History File (DHF).
- Design verification: With design verification, QMS protocols will ensure the conformance of design output with design input.
- Design validation: This step means that all devices (and related software) must be compatible with their intended use. You can use either stimulated or actual use conditions to validate.
- Design transfer: Ensure that the device design is translated into correct product specifications.
- Design changes: At times, your quality team may want to bring in some improvements in the design of a medical device. This is possible after review and approval.
- Design history file: Every medical device’s DHF will prove that that device was manufactured in accordance with approved plans.
You will notice that the design and development process requires the creation, maintenance, validation, and circulation of multiple files and documents between departments. This is easier to perform and track with an eQMS solution.
SimplerQMS’s design control software module helps you keep all design control-related documents in one place, thereby minimizing the chances of errors due to manual paperwork. Easily create document collections for each product, for example, for audit and approval purposes, then export them or share externally, or retrieve documents quickly as needed.
Production and Servicing Controls
Production and servicing controls ensure that your company’s QMS will cover all aspects of the production and servicing of medical devices, including inspection and measurement.
Test equipment is also included here.
You will also consider:
- Environmental controls. Any changes in the environment can affect the overall quality of your product.
- Contamination controls. The manufacturing area of the plant and the equipment used must be sterile.
- Personnel controls. Staff health, cleanliness, and clothing need to be checked regularly.
- Building controls. Sufficient space should be available for every aspect of the lifecycle of your products.
- Manufacturing materials control. Are the materials used for manufacturing specific devices compromised in any way? If there is the slightest doubt, such material must be suitably discarded.
- Servicing controls. You must have protocols in place for servicing medical devices and their associated software.
You will notice that this section emphasizes various crucial controls that are needed during the lifecycle of a medical device.
Once more, an eQMS solution can come in handy in ensuring these controls are in place.
With SimplerQMS, you can create multiple production and servicing control documents together without any manual paperwork. Our solution also allows you to schedule regular reviews of these documents, notify relevant personnel when changes are made, and store documents in one place.
All this helps your organization maintain the highest level of safety and quality in production and servicing.
All aspects of the lifecycle of a product must be controlled. This will also include third-party suppliers, including contractors and consultants, who supply components, materials, or services.
Such control is made possible when your QMS has well-defined and documented procedures that establish criteria for the selection and evaluation of potential suppliers before they are on-boarded.
The same applies to the re-evaluation of suppliers.
All such protocols, data, and records must be documented.
Using an eQMS solution with supplier quality management features like SimplerQMS will make it easier to select, evaluate, qualify, manage your suppliers, and ensure that your company’s compliance requirements are met.
Create and maintain Approved Suppliers Lists (ASLs), use forms and templates for various records such as contracts, surveys, evaluations, certificates, and incoming inspections, assign and track supplier-related tasks, and keep the records of all your supplier interactions securely in one place.
Recommended Reading: Medical Device Supplier Management Process (8 Steps)
Device Marketing Authorization and Facility Registration Process
This is one of the two supporting processes.
It can be audited as a linkage during the Management Process or during the Design and Development Process.
Your management must be aware of the requirements for device marketing authorization and facility registration. These details must be considered when a device is being designed.
Also, before distributing any medical device commercially in a particular market, you should obtain marketing authorization from the respective authority.
Medical Device Adverse Events and Advisory Notices Reporting
This process deals with adverse events related to any of your medical devices in the market.
For instance, a batch of implantable pacemakers is malfunctioning and complaints have come to you from several healthcare facilities. This is a serious case and your company needs to analyze the reasons for malfunctioning, ensure they don’t repeat and report to the concerned regulatory authorities.
This implies that you should have the capability to continuously collect and analyze data generated from every medical device that you have manufactured and marketed.
An eQMS such as SimplerQMS with in-built complaint management capabilities can make the process easier.
For example, using SimplerQMS, you also have the option of reporting incidents if the device has malfunctioned to such an extent as to cause serious injury/death or has contributed to a serious injury/death.
MDSAP: Key Considerations
When you are planning on undergoing the MDSAP audit program, note the following points:
- Audit duration. The audit cycle of MDSAP is over a three-year period. It consists of an initial certification audit (in two separate stages- 1 and 2); two surveillance audits in the next 2 years; a recertification audit in the third year.
- Audit requirements. Since MDSAP is a comprehensive audit with the involvement of multiple inspectors, you should be well prepared with training your key personnel. They should be available for answering the inspectors’ queries and provide the required documents/records as required.
- Resources. MDSAP is a comprehensive auditing program. It is expensive irrespective of the size or structure of the medical device manufacturer.
- Documentation and record keeping. There is a need to have a robust quality management system in place with efficient documentation and record-keeping. Traditional paper-based or hybrid quality management systems can themselves cause hurdles and challenges such as non-availability of records, delays in document management activities, lack of visibility into the system, etc. Thus, it is important to consider switching to a modern eQMS that can facilitate efficient document management, track and store all records securely in one place, assign tasks, notify personnel, and so on.
Frequently Asked Questions About MDSAP
What is the Difference Between ISO 13485 and MDSAP?
The main difference between ISO 13485 and MDSAP is that ISO 13485 is an international quality standard, and MDSAP is an audit program.
Furthermore, ISO 13485 is an international medical device quality management system standard that is acceptable across the globe. On the other hand, MDSAP is currently accepted in 5 countries – Australia, Brazil, Canada, Japan, and the USA.
Does FDA Recognize MDSAP?
The US Food and Drug Administration (FDA) is one of the signatories to MDSAP. It accepts MDSAP audits in place of routine inspections. However, FDA will still conduct initial visits and “For Cause” inspections.
Is MDSAP Mandatory in Canada?
MDSAP is mandatory in Canada. Since 2019, Health Canada has been accepting only MDSAP audit compliance reports from medical device manufacturers.
Is the EU Part of MDSAP?
The European Union (EU) is an official observer of MDSAP. As such, MDSAP is not yet accepted in the EU.
Who Can Perform MDSAP Audits?
MDSAPs audits are performed by Auditing Organizations (AOs), companies that meet the requirements for MDSAP auditing. Medical device manufacturers can get in touch with such an AO to perform an MDSAP audit for them.
Is MDSAP a Certification?
Yes, MDSAP is a certification. It allows a medical device manufacturer’s QMS to be audited using a single audit.
What are the Principles of MDSAP?
MDSAP is based on ISO 13485 requirements. In addition, medical device manufacturers will face specific country regulatory requirements (Australia, Brazil, Canada, Japan, USA) where they are selling their finished products.
What Processes Include the MDSAP Audit Scope?
The MDSAP audit scope has a total of 7 processes. There are 4 primary processes – Management Process; Measurement, Analysis, and Improvement; Design and Development; and Production and Service Controls. Purchasing is considered an enabling process.
There are 2 additional supporting processes – Medical Device Adverse Events and Advisory Notices Reporting and Device Marketing Authorization and Facility Registration.
The Role of QMS Software in Preparation for MDSAP
The Medical Device Single Audit Program is a unique opportunity for medical device manufacturers to access up to 5 international markets with a single QMS audit.
Its advantages have already been highlighted earlier in this article.
However, you do need to extensively prepare for a comprehensive, time-consuming, and expensive audit keeping in mind the requirements of multiple jurisdictions.
When a medical device company continues to use paper-based or hybrid QMS systems, it is very likely to face challenges in the form of tons of documents/records, storage issues, security problems, human errors, costs, and so on.
Considering that an MDSAP audit requires extremely meticulous documentation and record-keeping, a purpose-built medical device eQMS solution can be a great asset for any medical device organization.
Such a system first of all minimizes or completely removes challenges associated with paper-based document control.
Furthermore, it can provide great visibility into the system, track and monitor all processes, provide users with automated workflows and notifications, enable real-time collaboration between teams/departments, facilitate regulatory compliance support in multiple jurisdictions, and more.
Best QMS software solutions for life sciences support a vast array of core QMS processes such as document control, change management, training management, complaint handling, supplier management, non-conformance management, etc. that are closely related to processes evaluated during MDSAP audits.
Thus, investing in a thorough and powerful medical device eQMS, such as SimplerQMS, can make the challenging path of preparing for an MDSAP audit much smoother and simpler.
If you are interested in assessing whether an investment in a QMS software solution is in the best interests of your company, download our eQMS Business Case Template. It will help quantify the value of investing in such a solution and provide the tools to present it to senior stakeholders and decision-makers.
The manufacture and marketing of medical devices is certainly not child’s play.
You are one of the most regulated in the life science arena. Not surprising, considering that your finished products play a huge role in the lives of their users.
Therefore, it is natural that there are so many national and international regulatory standards and guidelines that you need to conform to before marketing your products.
Considering that audits are time-consuming, nerve-wracking, and expensive affairs, would it not be nice to have just a single audit and target multiple international markets?
Keeping this in mind, you have the Medical Device Single Audit Program. When you successfully comply with its directives, you can market in Australia, Brazil, Canada, Japan, or the US.
Note that it is a comprehensive auditing program conducted by authorized Auditing Organizations. You will have to go through a 7-step process over a three-year time frame.
Having traditional paper-based or hybrid QMS systems will only throw up hurdles and challenges. Rather than preparing for the MDSAP program, you will spend time, energy, and resources tackling existing challenges with your paper-based/hybrid QMS.
A much better approach is to invest in a purpose-built QMS solution instead.
If you are keen on taking the next step and investing in a QMS software solution, we recommend you book a demo with one of our Quality Solution experts and see how SimplerQMS can help your organization.