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Who regulates Medical Device? Global Medical Device Reporting Process

M

medev

#1
I am new in the world of Medical Device and was asked to set up a Global Medical Device Reporting process. I know I have a lot of reading to do and I am overwhelmed with the information from different bodies and health authorities. Kindly provide any guidance and recommendation where should I begin.
Thanks in advance and happy holidays!
medev
 
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Marcelo

Inactive Registered Visitor
#3
Re: Who regulates Medical Device?

Hello Medev, and welcome to the Cove.

You sure have a difficult task; the medical device world is a heavily regulated one, and developing a worldwide regulatory strategy is not an easy task (specially if your new to the field as you say).

Generally, each country or region has a regulatory authority, and they are generally related to the Health Ministry if the country. EUA has the FDA, Canada has Health Canada, Autralia has the TGA - Therapeutics Goods Administration, etc. The region type of regulation is better exemplified by the Medical Device Regulations, which are the general regulations of the European Community - but please keep in mind that each country has it´s regulatory authority - for example, MHRA in England - which might imposed additional regulations.

I don´t remember many online free resources that lists the regulatory bodies and regulations of any country - the only one i clearly remember right now is http ://www .trade.gov/td/health/regulations.html but it has just a few and some out-of-date countries - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

You can also take a look at the following site: http :// strategis .ic. gc.ca/eic/site/imr-ri2.nsf/eng/gr-01000.html - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS, under ISA (industry sector analysis) of each country you can find more info (not every countru has ISA-related info here).

Finally, maybe the easiest thing would be to contract a regulatory intelligence service, such as Tarius or Clinivation. Please mind you that i did not use these kind of services (i have a regulatory database but built form scratch by myself and only fro the countryies i´ve dealth with) so i cannot really recommend any...but i know a lot of people use them and they might help a lot.
 
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M

medev

#4
Re: Who regulates Medical Device?

This is great - Thanks Jennifer and Marcelo!

You are correct Marcelo, I realized that developing a global regulatory strategy is a monumental task to a newbie given the vast information and different regs out there ( role of CA, reporting criteria, not reportable, procedures to report, applicable forms etc ). I think I will start in the EU, EEA region, Switzerland, Canada and USA. Any information relevant to assessment and AE reporting decisions with medical device to CA, HA or Notified Boby in these member states and countries will be very much appreciated.
Thanks again
medev

:agree::thanx:
 
M

MIREGMGR

#6
Are you truly trying to be global, or is your scope actually limited to those countries (fewer than all of them) where your organization markets devices and is subject to the applicable device regulatory system?

In any case, you can usefully divide the world's countries into three groups based on their regulatory system approach:

Tier 1: Countries or regions with comprehensive freestanding regulatory systems, i.e. USA, Canada, EC, Japan, Russia, etc.

Tier 2: Countries with substantial regulatory systems, but which still rely on or make reference to a Tier 1 system or an international harmonization effort which itself is reflective of Tier 1 system approaches.

Tier 3: Countries which have no or only a cursory regulatory system of their own, and substantially rely on or make reference to a Tier 1 system, including accepting approval under such a Tier 1 system as sufficient evidence of local acceptability of the device.

Such an approach to categorization of countries does not actually reduce your work, but it may help to organize and prioritize it. In my experience, large projects such as yours are less overwhelming when an organizational concept is available, allowing you to focus for instance on the Tier 1 countries first since they have the greatest impact on the project outcome.
 
M

medev

#7
Thanks All,

I really appreciate all your reply.

To clarify, I need to develop vigilance reporting requirements for medical device incidents based on the directives and regulatory requirements for all devices where we market our products. We have devices in the market that are being reported to NCAs as if they were drugs using the ADE criteria instead of vigilance reporting requirements for Incidents.

I need to identify where our devices are being marketed, its classification and applicable reporting requirements. Based on this, we'll develop processes and procedures to comply and adhere to vigilance AE reporting requirements in accordance with the NCA in that jurisdiction.

I appreciate any input, references or attachments.

Thanks again,
medev
 
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