What are the basics of Medical Device Single Audit Program (MDSAP)?

[MakingADifference]

Happy New Year to all.

We are hoping to release our first product in the next month and once CE Marking is achieved, we will begin to target other territories. One of these was going to be Canada and I have read that the CMDR require you to be MDSAP certified before you can sell, as well as receiving clearance. I have a few questions that I was hoping people could assist with.

I had not been looking at the MDSAP program, has anyone gone through this?

Is this worthwhile, has it been adopted well? Do other countries mandate this?

What would be the average timescale for gaining MDSAP certification?

What costs are involved?

We are 13485 certified already and will hopefully receive CE clearance (under the MDR) shortly, is there a lot of work involved?

Sorry for all the questions, I am trying to gain some quick answers to determine whether we should look into it further or whether to just avoid Canada

Thanks for any help.

 

[Jean_B]

Have been through it.

Worthwhile over separate inspections of the regions, but perhaps less so if only selling in one or two of the regions. Also depends on the costs of your device as is so it's product specific. No other countries mandate it yet, and it only replaces 'regular' inspections.

For us it was an upgrade from ISO 13485 based and some separate (partly neglected) parts. Took about half a year to get in order cross-functionally, with a dedicated person acting as expert (obtain information, assess gaps, teach specific parts, review) and coordinator.

Certification costs were about 50k euro at the time. Incurred expenses on own side were not tracked.

Get yourself the audit approach document and run through the tasks and questions. Pay special attention to the region specific questions.

 

[MakingADifference]

Thanks Jean_B, this really helps.

Am I correct in saying that we cannot sell in Canada without MDSAP? We do want to sell in Australia, Brazil and Japan but if it is not mandated, it is probably not worth our while at this point in time.

 

[DannyK]

You are right.
You cannot sell a class II, III or IV medical device in Canada without MDSAP.
You can sell to the other countries without MDSAP.
The process is expensive and there are significant delays to get MDSAP.

 

[MakingADifference]

Thanks Danny.

If we do not go for MDSAP but pursue regulatory clearance in Brazil let's say, are we required to have an external audit against the countries standards? We hold 13485 and was wondering whether countries just accept this or is it different for each country?

 

[Jean_B]

Brazil may require a B(razil) GMP portion and INMETRO/MET audit. Those will not go away with MDSAP, but our perception is the auditor then gives a bit more leeway to the QMS stuff and really digs into the active/device specific matters for those audits. Because of the costs of registration activities and such compliance activities do look into whether it's worth it. Those costs aren't always taken into account for the profit calculation.

 

[Edward Reesor]

Just to weigh in here as a Canadian based manufacturer. Although MDSAP is accepted by USA, Canada, Brazil, Australia and Japan, Canada has made it mandatory (I.e. the only acceptable form of QA for a company wishing to sell their products in Canada). Therefore, a company must weight the costs of certification versus the net profit generated by their products. You need to contact an Auditing Organization (AO) to get quotes and timelines for your your case, and please be aware that each country applied for on the application carries an additional cost. For example, we sell in USA and Canada and if we wish to consider placing Brazil on the certificate, their requirements add to the auditing cost.

Much has changed since it was implemented a few years ago, so costs and availability of an AO may have improved. I have heard of some companies using their primary distributor or manufacturing partner to "piggy back" onto their certification.

Please note that making MDSAP mandatory in Canada was well intentioned, however several companies have withdrawn their products from the Canadian marketplace due to the initial cost. Some have found work arounds, but Health Canada remains silent on the net effect of its implementation.

 

[yodon]

This doesn't fall into the 'quick answer' category but the FDA has some good info:

• MDSAP Companion Document
• MDSAP Forms and Procedures (a ton of handy and informative links)