Are you one of the many Medical Device Manufacturers who is struggling to figure out the potential benefits of the Medical Device Single Audit Program (MDSAP)?
Well, here we are, to assist you. Many Medical Devices Manufacturers all over the world have various misconceptions when it comes to the cost and duration of the MDSAP Audits as compared to the more conventional ISO 13485 Quality Management Systems.
Let’s learn more about MDSAP, its key processes, and the benefits of this program.
What is MDSAP?
The Medical Device Single Audit Program was launched by the International Medical Device Regulators Forum (IMDRF) IMDRF in 2012 with the aim of developing a universal standard for quality systems of medical devices and to cover the country-specific regulatory requirements of global marketplaces and grant marketing access to the Medical Device Manufacturers in the countries worldwide on the basis of a Single Audit.
What is the aim of MDSAP?
The main aim of the MDSAP is to reduce the regulatory burden on the manufacturers to gain global market access and facilitate international product launches and approvals without going through multiple country-specific regulatory and quality audits.
Which Countries and Regulatory Agencies participate in the MDSAP?
- United States: The US FDA accepts the MDSAP certificate as evidence of the Manufacturer’s compliance with GMP requirements listed in the 21 CFR part 820. Additionally, the US FDA can perform initial visits or inspections to the manufacturer under certain cases mostly triggered based on regulatory pathway, product risk or field events.
- Canada: In 2019, Health Canada decided to accept only the MDSAP Certification as evidence of the Manufacturer’s Quality Management System and the conventional CMDCAS Certificates were no longer considered to be valid. Hence the Manufacturers looking to market or to continue marketing their Medical Devices in Canada needed to have a valid MDSAP certificate in order to receive a Medical Device License from Health Canada.
- Australia: Just like Canada, the Therapeutic Goods Administration (TGA) Australia is also fully dependent upon the MDSAP Certificate to approve the manufacturers in terms of complying with the QMS requirements.
- Japan: The Ministry of Health, Labour and Welfare (MHLW) of Japan has authorized the use of MDSAP Certification as evidence of the Manufacturer’s commitment to Japanese Medical Device QMS requirements.
- Brazil: The ANVISA accepts the MDSAP Audit results for the Manufacturer’s QMS compliance.
Who are the Key Members of the MDSAP?
- Regulatory Authority (RA): The governing body of the MDSAP is the Regulatory Authority Council (RAC) which includes two senior members from each of participating MDSAP countries, listed above. The main responsibility of the Regulatory Authority is to appoint the Auditing Organizations (AO) and to grant Medical Device Licenses to Manufacturers post the receipt of MDSAP Certification.
- Auditing Organization (AO): Responsible for conducting an audit of the manufacturer, granting MDSAP certificates to the manufacturer, and reporting the results of the audit to the Regulatory Authority. A few currently active Auditing Organizations are shown in the figure below:
3. Manufacturer: Responsible for complying with the regulations set forth by the Regulatory authority, applying for MDSAP certification and Device License in the desired jurisdictions.
How does the MDSAP Audit Process Work?
- The Auditing Organisations must conduct an audit of the manufacturer according to an acceptable set of requirements. Further, the same requirements are used by the Manufacturers to prepare themselves prior to the MDSAP Audit. The primary document that is used by the Auditing Organizations is primarily in line with the ISO 13485 requirements and combines the country-specific requirements of all the participating MDSAP Countries in a single document.
- The Manufacturer has the authority to select the Auditing Organization and the manufacturer shall verify the reputation and the auditing experience of the Auditing Organization during the shortlisting process.
- Once the Auditing Organization is shortlisted and hired, the manufacturer has to undergo an annual audit as a part of a three-year certification cycle which is goes as follows:
- Initial Audit (Year 0): This comprises Stage 1 Audit wherein the manufacturer’s Quality Procedures are reviewed as part of readiness for the next stage of the audit.
- Surveillance Audit (Year 1 and Year 2): These are periodic audits conducted in Year 1 and Year 2 of the certification cycle in order to have a vigilant oversight of the manufacturer’s QMS. Further, any changes made by the manufacturer to the Product/Process from the time of the initial certification Audit shall be assessed in these audits as well.
- Recertification Audit: This audit is the complete review of a manufacturer’s QMS and may be exhaustive at times since this is the last phase of the Audit cycle and AO ensures that manufacturers continue to meet the MDSAP Requirements in the upcoming cycles as well.
Which Key QMS Processes are reviewed by the AO during the MDSAP Audit?
The MDSAP Audit Model evaluates the manufacturers on every aspect of the QMS similar to the ISO 13485 Audit Approach. Refer below for the key processes which lay the foundation of an MDSAP Audit.
What is the cost of undergoing the MDSAP Audit?
The cost of an MDSAP Audit completely depends upon the scope of the audit, the processes undertaken by the manufacturer, and the time taken by the Auditing Organization to complete the Audit.
Often Manufacturers decide to proceed with both MDSAP and ISO 13485 in order to maintain access to several markets with only one audit. If you are a Manufacturer and confused about the MDSAP Approach and concerned about complying with the MDSAP requirements?
Don’t Worry!
Elexes is here to assist you. Our dedicated team has years of experience in supporting our clients to pass their MDSAP Audits and marketing their devices freely in their respective jurisdictions. Please feel free to contact us at connect@elexes.com for further details.
