Global Medical Device Requirements

[Watchwait]

I am seeking the holy grail: a single source that has identified the medical device quality system requirements for "other" parts of the world, e.g. Middle East, South America, Taiwan, China, India, Mexico, etc. Whereas there is abundant information on the US, the EU, Canada, there seems to be an equivalent shortage of defined QS requirements for 2nd & 3rd world markets.

Forget GHTF. Their work is interesting, but way too general for our purposes. We have a medical device we are looking to market to these "other" areas of the world & the process for determing these requirements is haphazard, to say the least. Google is nice - but it can't be the sole source of an international QS requirements investigation.

Knowing that we cannot be the 1st organization looking to do so, I'm convinced someone, somewhere must have accumulated a database that would reflect exactly what we're seeking. Granted, requirements change constantly, but since all these areas represent significant medical device marketing opportunities the requirements must exist in some form & place.

Once located, I promise to share this information with the world at large...

 

[chris1price]

Hi

The only free source I know of is: http :// www. ita. doc. gov/td/health/regulations.html - LONG DEAD LINK UNLINKED

Chris

 

[Roland Cooke]

There is a company, I forget which (possibly Quintiles), that sends out a binder once a quarter or so, with some or all of this information (it contains at least the European stuff).

It is certainly detailed, with a pricetag to match.

 

[Marcelo]

Not the whole world, but "International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products, Second Edition"
by Charles Sidebottom can be an interesting start. You can read it online at http://www.pharmaceuticalnetbase.com/ejournals/books/book_summary/toc.asp?id=1998 if you have access.

Anyway this in an interesting point. In the ISO IEC 62 general meeting and the ISO TC 121 meeting which i recently attended, a lot of people told me that they had problems finding information about the regulatory process in Brazil. The fact is that the brazilian regulatory agency (ANVISA) does not provide clear information in english for the medical devices sector (they do provide for drugs).

One of the actions i´ve imagined for some time to take is to create a document and put in on one of my blogs to share, but i really am no having the time do this kind of work rightt now.

 

[zhang126]

Clinivation has such information service called WorldView

http://www.clinivation.com/worldview/index.php

 

[NB2010]

One of the actions i´ve imagined for some time to take is to create a document and put in on one of my blogs to share, but i really am no having the time do this kind of work rightt now.

Could you share some knowledge about S.E Asia/Pacific countries' regulation? Or point me where to find such information. Thanks.

 

[SteveK]

Hi,

There is the ASEAN - try:

http://accsq-mdpwg.org/

 

[VKanani]

Hi,

I am a MS RA student studying the Brazilian regulations as a part of my coursework. I have a device which is a "bone growth stimulating matrix embedded with a novel osteoinductive molecule".

Since this is a combination device, is anyone aware of any ANVISA regulations specific to combination device ?

 

[Roland Cooke]

Have you tried contacting ANVISA directly?

 

[VKanani]

I would really appreciate any help. Elsmar does not let me type an email address, but you can send me a personal message. If you feel comfortable, you can email me some tips on how to go about it. Again, I would really appreciate any professional help.

Thank you.