Which Medical Device Regulatory Body you rate as the best

Which Medical Device Regulation you rate as the best.

  • Australia TGA

    Votes: 0 0.0%
  • Brazil ANVISA

    Votes: 0 0.0%
  • China CFDA

    Votes: 0 0.0%
  • Europe MDD

    Votes: 0 0.0%
  • Japan PMDA

    Votes: 0 0.0%

  • Total voters
    4
  • Poll closed .
Elsmar Forum Sponsor
M

MIREGMGR

#2
All have major flaws. I don't see any other one as being in the same league as FDA, though.

I chose to re-spin "user friendliness" as immediate access for interpretations and discussion of borderline cases. I don't care whether they're nice. On the other hand, I greatly value being able to pick up the phone and talk to a manager in the Office of Compliance, or the senior person responsible for a particular Guidance.
 
#5
This is a great question. None of them are perfect but the FDA's data structure, information available, their professional/friendly attitude, together with ease of use and accessibility is far superior to the others.
 
J

Julie O

#6
I don't see how anyone can top FDA as an agency. I'm actually quite a fan of the EU regulatory framework, but they have too many players in the mix for effective regulation, I think. And, to do them justice, are much newer at the game, like most of the other agencies out there.

A year or two ago, an FDAer I spoke with at a global harmonization forum told me that everyone always fusses at them about not being more "flexible" when it comes to harmonizing, but...whenever they get together with the other agencies, the other agencies don't want FDA to be flexible. They want FDA to show them how they do it, so they can do the same.

That was my impression from talking to regulators from the other agencies as well.
 
#7
I agree with the EU Julie, it's a mess and I voted for the FDA because i find it much easier to navigate than the rest. The responses I get from FDA are more professional than responses from the EU as well. In fact I find the FDA staff to be a highly experienced, approachable and down to earth, but I find the opposite with the EU.
 
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