MDSAP Pilot Program Participating Countries
Representatives from the following international coalition of countries participated as pilot developers in the MDSAP pilot program:
- The Australian Therapeutic Goods Administration (TGA)
- Brazil’s Agencia Nacional de Vigilancia Sanitaria (ANVISA)
- Health Canada
- U.S Food and Drug Administration (FDA) and
International Regulatory Authorities Participation
Every Regulatory Authority that participated in the MDSAP pilot program were considered to be equal partners. The results obtained from the final MDSAP pilot report are based on data accumulated over the course of the three-year pilot. It is expected that more Regulatory Authorities will participate in MDSAP and become active participants in either the pilot program or the implemented MDSAP program.
The observer status and role of European Union were discussed. However, the EU’S participation was declined and this could have been ascribed to the number of member countries in the Union.
Observers of the MDSAP Pilot Program
Japan’s Ministry of Health, Labour and Welfare (MHLW) together with the Pharmaceutical and Medical Devices Agency (PMDA) were observers to the Regulatory Authority Council (RAC) and Subject Matter Expert (SME) in 2013.
The World Health Organisation (WHO) was also an observer to the SME Working Group whereas the European Union participated as observer Status in 2014.
For IVDs pre-clearance process, WHO serves as a member of the IMDRF-MDSAP working group and as an observer to the MDSAP. WHO has shown a willingness to adapt and inculcate MDSAP processes to a certain extent in their pre-qualification program.
MDSAP – Roles of Participants and Observers
MDSAP roles involve both participants and observers. Below are their roles explained in detail.
- The Regulatory Authority participants provide the resources to support the development, implementation, maintenance and expansion of MDSAP.
- The Regulatory Authority participates actively in the process of recognizing, monitoring and re-recognizing Auditing Organizations under the framework of the IMDRF and MDSAP.
- The participating Regulatory Authorities have committed to the use of MDSAP deliverables during the pilot in order to assess program success.
- Each Regulatory Authority participant is also represented by two senior level managers or the MDSAP Regulatory Authority Council (RAC) which is the MDSAP’s governing board.
- A Regulatory Authority who is an observer may attend MDSAP, SME, WG meetings, assessments and other activities but are not to utilize MDSAP program deliverables to replace or supplement it’s regulatory scheme deliverables of let portions of these deliverables.
- The observers are represented on the MDSAP RAC by one senior level manager.
Pilot MDSAP “Criteria for Success”
The MDSAP Subject Matter Experts Working Group came up with a plan to gather evidence for a “Proof of Concept” of the MDSAP pilot.
There are 8 performance indicators to determine the success of the pilot. The criteria for success based upon audit reports and nonconformities. These criteria use a method for data collection, sampling method of analysis and Targets which were defined for each indicator.
More information on these criteria can be seen in MDSAP P0007 Proof of Concept for MDSAP pilot document.
How the MDSAP Pilot Audit was Conducted
MDSAP Pilot audit will be conducted by an Auditing Organization according to the FDA. This will be done through the use of applicable documents developed by the participating Regulatory Authorities for the implementation of the program pilot.
The following policies and procedure were detailed by the FDA on their website:
- Auditors must follow the sequence of tasks specified in the audit model- MDSAP AU P0002 in order to ensure consistency across auditor teams and auditing organizations.
- The auditing organization determines the audit duration based on planned audit tasks – MDSAP AU P0008 in order to ensure consistency across auditing organizations.
- The audit duration will not exceed the accumulated time of multiple audits and inspections they would undergo if the participating Regulatory Authority perform their inspections according to their governing policies.
- The auditing organization writes an audit report for each audited site using a standard fillable template specifically designed for medical device regulatory audits.
- Nonconformities identified during an audit are graded on a scale from 1 (least critical) to 5 (most critical) according to explicit criteria – GHTF/SG3/N19.
- High-grade nonconformities may trigger the performance of an unannounced audit.
- The manufacturer provides, and the auditing organization reviews, remediation plans and evidence of implementation of these plans according to a specified timeline- MDSAP AU P0027.
- Auditing organizations will share the audit outcomes with the participating Regulatory Authorities to support their pre-market and post-market programs.
- Upon successful certification audits, auditing organizations issue MDSAP – SPECIFIC certification documents stating compliance to MDSAP audit criteria – MDSAP AU P0026
MDSAP Pilot Grading System
The MDSAP grading system eliminates the classification of major and minor conformities that the IS auditing system instituted. With the MDSAP grading system, there are no longer majors and minors concerning nonconformities. Instead, the MDSAP grading system uses a 5-point grading scale which ranges from 1 (LEAST critical) to 5 (MOST critical). For more information you can access the GHTF/SG3/N19:2012 (Review the last two pages).
MDSAP Pilot: Mid-point Status Report
This represents was released in August, 2015. It revealed that 45 manufacturers had registered to participate as of July of 2015.
The FDA faced challenges in trying to get companies that dealt in medical devices to sign on to MDSAP. These challenges could have been due to the fact that there were only few qualified auditing organizations available to carry out the audit.
The FDA states in the report that “As more Auditing Organizations become authorized to conduct MDSAP audits, a continuation of the positive slope is anticipated. It is too early to project whether target goals will be met”.
Under MDSAP, only organizations recognized by the Canadian Medical Devices Conformity Assessment System (CMDCAS) are authorized to carry out audits. There were 13 CMDCAS registrars identified as eligible to participate in the MDSAP pilot and only 6 organizations had signed up and undergone application review and assessments as at July, 2015. By the conclusion of the MDSAP pilot, all 13 organizations had completed these assessments.
Another factor to participation may have been that if an organization had a notified body that was not approved for MDSAP audits, they would need to have another assessment in addition to the regular ISO 13485 audit.
The proof of concept criteria goal was 10% participation level which translates to about 330 manufacturing companies for the MDSAP pilot.
Who Performs the MDSAP audit?
Only approved organizations could apply during the MDSAP pilot. In total, there were only 11 of them. However, at the end of the pilot application, other organizations were being accepted for the consideration for the approval to perform MDSAP audits.
An organization must submit an application to the MDSAP and be approved in order to be recognized by the program as an approved auditor.
MDSAP Pilot: List of Auditing Organization Participants
The following auditing organizations participated in the MDSAP pilot:
- bsi group America Inc.
- DEKRA Certification bv
- Interested testing services NA Inc.
- Laboratoire National De Métrologie et D’essais GMED Certification division
- Lloyds Register Quality Assurance Inc.
- National Standards Authority of Ireland (NSAI)
- QMI SAI Canada Limited
- TUV Rheinland of North America Inc.
- TUV SUD America Inc.
- UL Medical and regulatory services
Expected Improvements from Implementing MDSAP Pilot Program Audit Model
The MDSAP Pilot was expected to improve the predictability of audit outcomes through:
- The use of standard MDSAP audit model by multiple international regulatory authorities and auditing organizations
- Enhanced auditing organization recognition criteria
- Monitoring of Auditing Organizations by the participating Regulatory Authorities
- The grading of any nonconformity using objective criteria to characterize the significance of the finding
- The reporting of the audit outcomes using a standard report template.