The Cove Business Standards Discussion Forums
Statement of Cooperation Among FDA - TGA - ANVISA - HPFB
UL - Underwriters Laboratories - Health Sciences
Statement of Cooperation Among FDA - TGA - ANVISA - HPFB
Statement of Cooperation Among FDA - TGA - ANVISA - HPFB
Statement of Cooperation Among FDA - TGA - ANVISA - HPFB
Statement of Cooperation Among FDA - TGA - ANVISA - HPFB
Statement of Cooperation Among FDA - TGA - ANVISA - HPFB
Statement of Cooperation Among FDA - TGA - ANVISA - HPFB
Statement of Cooperation Among FDA - TGA - ANVISA - HPFB
Statement of Cooperation Among FDA - TGA - ANVISA - HPFB
Statement of Cooperation Among FDA - TGA - ANVISA - HPFB
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Statement of Cooperation Among FDA - TGA - ANVISA - HPFB

Monitor the Elsmar Forum
Sponsor Links

Courtesy Quick Links

Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services

International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

Ajit Basrur
Claritas Consulting, LLC

International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Some Related Topic Tags
anvisa, audits and auditing, australia, australia tga, brazil, canada, fda (food and drug administration), health canada, tga (therapeutic goods administration), united states (usa), medical devices
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 21st December 2012, 02:05 PM
Ajit Basrur's Avatar
Ajit Basrur

Total Posts: 6,205
Look! Statement of Cooperation Among FDA - TGA - ANVISA - HPFB

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.
Thank You to Ajit Basrur for your informative Post and/or Attachment!

Sponsored Links
  Post Number #2  
Old 2nd January 2013, 04:14 AM
Gert Sorensen's Avatar
Gert Sorensen

Total Posts: 1,278
Re: Statement of Cooperation Among FDA - TGA - ANVISA - HPFB

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.
  Post Number #3  
Old 28th August 2014, 05:52 PM

Total Posts: 85
Re: Statement of Cooperation Among FDA - TGA - ANVISA - HPFB

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??
Thanks to gramaley for your informative Post and/or Attachment!
  Post Number #4  
Old 28th August 2014, 06:24 PM
Reg Morrison

Total Posts: 433
Re: Statement of Cooperation Among FDA - TGA - ANVISA - HPFB

In Reply to Parent Post by gramaley View Post

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.
  Post Number #5  
Old 28th August 2014, 06:33 PM

Total Posts: 85
Re: Statement of Cooperation Among FDA - TGA - ANVISA - HPFB

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.

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > > >


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off

Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Boeing and Embraer sign Cooperation Agreement Sidney Vianna Coffee Break and Water Cooler Discussions 1 16th April 2012 03:38 AM
Lack of Management Commitment and Cooperation in Implementation of QMS! Sardokar Quality Manager and Management Related Issues 36 1st July 2011 07:11 AM
Fighting for Cooperation to Participate in the Development of our QMS EntryLevelQualityMgr Career and Occupation Discussions 9 19th February 2011 10:12 AM
ILAC - the International Laboratory Accreditation Cooperation Marc Definitions, Acronyms, Abbreviations and Interpretations 0 1st February 2008 03:16 PM
Mission Statement - Employees should know our company Mission Statement verbatim? John Lorencen ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23 24th March 2006 05:17 PM

The time now is 11:00 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.

Misc. Internal Links

NOTE: This forum uses "Cookies"