CE based registration for specific countries

NewRegMan

Starting to get Involved
#1
Dear experts,

I urgently need to know which country has its medical device regulation based on the CE mark.

The countries are:

Mexico
Panama
Brazil
Hong Kong
Canada
Malaysia
Algeria
Chile
Argentina

Any quick response will be very appreciated.

Thank you guys in advance & Best regards,
NewRegMan
 
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S

SteveK

#2
Hong Kong has "Essential Principles" which is a virtual copy of the "Essential Requirements" - Annex I of the MDD 93/42/EC for CE Marking if that is any help.
 

somashekar

Staff member
Super Moderator
#3
Dear experts,

I urgently need to know which country has its medical device regulation based on the CE mark.

The countries are:

Mexico
Panama
Brazil
Hong Kong
Canada
Malaysia
Algeria
Chile
Argentina

Any quick response will be very appreciated.

Thank you guys in advance & Best regards,
NewRegMan
At least not Canada & Brazil ...
 
M

MIREGMGR

#4
I don't think any of those countries regard a CE Mark on a product label as legally sufficient proof of device regulatory acceptability, in the absence of prior supportive regulatory actions for that specific product by the manufacturer and/or a locally based distributor.
 

somashekar

Staff member
Super Moderator
#5
I don't think any of those countries regard a CE Mark on a product label as legally sufficient proof of device regulatory acceptability, in the absence of prior supportive regulatory actions for that specific product by the manufacturer and/or a locally based distributor.
You are correct, However the OP seems to be asking on the type and style of acquiring CE mark being largely recognized as valid amongst the listed countries.
 
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