Regulatory Requirements for ISO 13485 - Which country to decide?

K

kbng82

#1
i am new in ISO and now trying to get company certified to ISO 13485:2003 besides ISO 9001:2000. i work in a small medical devices company and customer based in Taiwan, Bangladesh, New Zealand, China, Indonesia, Thailand, Malaysia, USA, etc. In order to determine which regulatory requirements to take into account to fulfill, do i need to go through regulations of every country where our customers come from and comply with all of them? any directive for all this? what about FDA? i am new in this and wish that someone might make it clear for me so that i can proceed more. many thanks.
 
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R

Roland Cooke

#3
Most companies rely on their various national distributors to provide this information, and it usually works fine.

However the RESPONSIBILITY remains that of the manufacturer.
 
K

kbng82

#4
thanks for your reply. i'd been to the website you recommend and it did help me a lot.

in case of referencing the regulatory requirements of various countries in ISO documentations, do i have to be specific to mention about the name of the regulations in each customer countries or can i mention about Global Harmonization Task Force (GHTF) "Essential principles of safety and performance of medical devices" for example, as one of the reference documents of regulations to comply with, since some of the countries are members of it or trying to standardize their regulations with that?

thanks for any guidance.
 

Al Rosen

Staff member
Super Moderator
#5
thanks for your reply. i'd been to the website you recommend and it did help me a lot.

in case of referencing the regulatory requirements of various countries in ISO documentations, do i have to be specific to mention about the name of the regulations in each customer countries or can i mention about Global Harmonization Task Force (GHTF) "Essential principles of safety and performance of medical devices" for example, as one of the reference documents of regulations to comply with, since some of the countries are members of it or trying to standardize their regulations with that?

thanks for any guidance.
You must be specific as the GHTF Essential principles is a guide for the countries to use to harmonize and is not a regulation.
 
W

wrodnigg

#6
When you want to sell your product in the EC, you have to have an "authorized representative". Then the national law of the country, where your authorized representative is located, apply (the MDD laws differ slightly from country to country, so if you can chosse, you should pick carefully).

In case of the countries you mentioned, you will have to undergo seperate registration processes for most of these countires...
 
K

kbng82

#7
thanks for your reply.

i understand that we need to undergo separate registration process for medical device in the customers' countries. but my another question is, does the registration of medical device alone fulfills the compliance to regulatory requirements as required by ISO 13485:2003?

for example, do i need to check with each separate customer country if the design of product can be exempted or the design and development is a must by medical device manufacturer? is there any contraints in dimensions of the medical devices in relation to safety and performance of the medical device? is there any specified retention time of medical devices in the specific country?

for information above, do me have a source to check from which can apply to most of the country?

thanks for reply.
 
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