Ajit Basrur

Staff member

The United States Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Surveillance Agency (ANVISA), and the Canadian Health Products and Food Branch (HPFB) (collectively ?the Participants?) seek to strengthen existing mutual cooperation in the scientific and regulatory area of medical devices through the development of the Medical Device Single Audit Program (MDSAP), as documented by this Statement of Cooperation (SOC).

The goal of the MDSAP is to provide for more effective, efficient and less burdensome regulatory oversight of the quality management systems of medical device manufacturers. The implementation of the MDSAP is intended to allow for a single audit to satisfy the regulatory requirements of the Participants.

The objectives of the MDSAP are to:

Operate a single audit program that provides confidence in program outcomes;

Enable the appropriate regulatory oversight of medical device manufacturers? quality management systems while minimizing regulatory burden on industry;

Promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among Participants, while respecting the sovereignty of each country;

Promote, over the longer term, greater global alignment of regulatory approaches and technical requirements based on international standards and best practices;

Promote consistency, predictability and transparency of regulatory programs by standardizing oversight practices and procedures of Participants over third-party auditing organizations, and the practices and procedures of participating third-party auditing organizations; and

Leverage, where appropriate, existing conformity assessment structures.

The Participants, in accordance with their respective legal authorities, intend to develop a joint work plan as appropriate for the MDSAP. This work plan is intended to enable the pooling of technology, resources, and services to improve the safety and oversight of medical devices in a more efficient manner that is also less burdensome for industry.

Each Participant to this SOC intends to fund its its participation in activities under this SOC. All such participation is subject to the availability of appropriated funds (where applicable), personnel, and other resources. Each Participant intends to maintain the confidentiality of the information shared under this program according to its own procedures and policies as permitted by its laws.

This SOC is not intended to create binding obligations under international or domestic law. Nothing in this SOC is intended to negatively affect the Participants? responsibilities or ability to carry out their regulatory responsibilities and programs in accordance with their respective laws and regulations.

This SOC may commence upon signature of all the Participants. A Participant may discontinue its participation in the development of the MDSAP upon sixty (60) calendar days? written notice to the other Participants.

Gert Sorensen

Forum Moderator
This is definitely going to stir up things in the QA/RA communities, but I am personally in favour of the program. I do believe that in the end it will be advantageous to the industry to have the systems aligned globally; it will level the playing field for the companies, and it will allow the authorities to better focus their ressources.


Involved In Discussions
It is a single audit, but it combines multiple QMS and even other regulations outside QMS.

It is estimated that the cost will be 25%, 35% or 100% more than what is currently paid to get CMDCAS/CE certs. '

I'm told by an FDA person close to MDSAP that Health Canada has 3500 medical device licensed companies. The FDA has 20,000 registered firms in the US and 32,000 total worldwide. Brazil is a closed market (30% tariff) for most manufacturers.

Canada and Brazil are the only two countries that are considering adopting this as a regulatory requirement. FDA and Europe have to keep it voluntary, for a wide range of reasons. So its going to be skipped over by manufacturers abroad that sell into the USA, ironically the very same manufacturers the FDA wants assessed to their regulatory requirements. Keeping it voluntary is killing the value to FDA, just as it did the last three attempts at third party programs.

What is missing is the incentive to use it. The incentives are all based on making regulators happy, not industry. It may sound cold, but reality is what it is.

Offering industry a voluntary system that is more expensive than what they are using makes no sense at all. This could actually further deter medical device manufacturers from taking an interest in Canada and Brazil, further shrinking their access to an already short supply of medical devices. This has a greater potential to do more damage to healthcare for those countries that make it mandatory.

On the flip side, it will do nothing to protect US citizens from the mostly unregulated medical device industry abroad, since it will remain voluntary to all medical device manufacturers worldwide, that sell into the US.

Consider that 1% of Korean manufacturers were inspected by FDA during the FDA's peak inspection year. Would they be wise to sign up for MDSAP to get a year off from an FDA inspection that has a 1/100 chance of occurring? Really?

There are more than 40,000 medical device manufacturers worldwide and 244 countries trading medical devices for the sake of all. There has to be a better balance of trade to healthcare protection to meet the needs of all. At the end of the day, manufactures ask themselves that one question ?Is it worth it??
What is missing is the incentive to use it. The incentives are all based on making regulators happy, not industry.
In my professional experience, reduction of external audits is a HUGE incentive for large corporations. Most of them, especially in the highly regulated sectors suffer from audit barrage and fatigue. They spend so many resources supporting external auditors that, if they could reduce the number of audits they have to endure, it would be extremely attractive.


Involved In Discussions
Keep in mind, this program was not intended to help big companies, but to gather information on smaller ones, especially overseas. However, it was surprising to listen to representatives from two of the largest medical device manufacturers air their concerns about MDSAP. One worried about spending millions more on the audits of their many offices. All of them loathed the idea of these reports then getting circulated among the IMDRF committee for further action.

This is actually the very first third party program where I have heard so much complaining by large corporations, but I don't think its a money issue as much as it is a fear that something will be out of place per one regulation or another, and the other IMDRF members are all going to know about it.