In 2012, The International Medical Device Regulators Forum (IMDRF) recognized the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices. It was at that point that the concept for the Medical Device Single Audit Program (MDSAP) was introduced.
Over the past 3 years and into 2016 significant progress has been made towards the full realization of the MDSAP program including the MDSAP Pilot Program which started January 1, 2014 and is expected to continue until end of December 2016.
MDSAP Basics and Benefits
The MDSAP program is a comprehensive approach to quality system auditing and includes the development of an international coalition of countries devoted to pooling resources, technology, and services to enhance the safety and oversight of medical devices worldwide. Therefore the MDSAP program will be beneficial to manufacturers of medical devices who are interested in marketing and selling devices in Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan ((MHLW and PMDA), The United State of America (FDA).
The MDSAP program is voluntary and will rely on one single assessment of the manufacturers quality management system annually with a full certification cycle of three years. This will greatly reduce the number of regulatory audits and inspections a medical device manufacturer must participate in. The manufacturer will be able to choose an MDSAP recognized auditing organization. The goal of the single assessment will be to show compliance with the requirements of the five participating countries. Each country defines how the MDSAP results are implemented according to its legislation. After the MDSAP assessment the results (audit report) will be uploaded into a database that will be accessible by participating regulatory authorities.
MDSAP Audit Criteria and ISO 13485
The audit criteria of the MSDAP program will include the requirements of ISO 13485 and the applicable requirements of the participating regulatory authorities. In addition, other requirements will be included in the program such as specific requirements of each regulatory authority for product and company registration, licensing requirements and any particular requirements related to the reporting of adverse events.
One important provision includes the ability for a manufacturer to exclude the requirements of any jurisdiction in which the manufacturer does not intend to supply medical devices. This means that at a minimum the requirements of ISO 13485 will be included in the MDSAP auditing criteria along with only the applicable regulations of the authorities in which the company intends to sell a device.
MDSAP Latest News
On February 11, 2016 the FDA announced its decision that effective March 31, 2016, they will no longer accept ISO 13485:2003 voluntary audit reports with an audit end date of April 1, 2016 or later. FDA will continue to accept these audit reports with audit end dates of March 31, 2016 or earlier; however, reports must be submitted within 90 days following the conclusion of the audit.
After March 31, 2016, MDSAP will be the primary means for a medical device manufacturer that markets its devices in the United States to participate in a Third Party Audit program. Under MDSAP, FDA will accept MDSAP audit reports as a substitute for routine inspections.
Previously on December 4, 2015, Health Canada also announced its decision to end the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program.
The CMDCAS program will be replaced by the MDASP program for any manufacturer that intends to sell a device in Canada even if that device is sold only in Canada. This transition will begin at the conclusion of the MDSAP pilot program. However manufacturers will have two years to transition, during which Health Canada will accept certificates under both the MDSAP Program and the CMDCAS program. When the transition ends on January 1, 2019, only MDSAP certificates will be accepted by Health Canada going forward.