Applicable Medical Device Wifi regulations for various Countries

[qarauser]

What are the regulations applicable if Wireless (Wifi) module part of Medical Device for the following countries?
Argentina
Australia
Brazil
Canad
Caribbean
Chile
China
Colombia
Hong Kong
Israel
Japan
Korea
Malaysia
Mexico
New Zealand
Nordic
Norway
Peru
Philippines
Puerto Rico
Russia
Singapore
South Africa
South East Asia
Switzerland
Taiwan
Thailand
Turkey
United Arab Emirates
Vietnam

Thanks in Advance!

 

[shimonv]

Hi qarauser,
WiFi is a relatively big topic and you are asking about 30 questions in one post

To get better response I suggest you read some standards and guidelines about WiFi and then ask more specific question.

Cheers,
Shimon

 

[qarauser]

Hi,

Have gone through the standards. I could find the requirements for USA and EU.

 

[shimonv]

Hi,
Have a look at FDA page on Wireless Medical Devices, and FDA guidance on Radio Frequency Wireless Technology in Medical Devices.


-Shimon

 

[dappong]

Hi,

Apart from medical device registration, the Korea government requires KC certification for medical devices equipped with WIFI functionality. National Radio Research Agency(rra.go.kr) is where controls KC certification. You might as well take advantage of using MRA agencies if you can have option.

Thanks,
DYS

 

[medwise]

RCM and RSM compliance with Australia and NZ respectively

 

[QAengineer13]

What are the regulations applicable if Wireless (Wifi) module part of Medical Device for the following countries?
Argentina
Australia
Brazil
Canad
Caribbean
Chile
China
Colombia
Hong Kong
Israel
Japan
Korea
Malaysia
Mexico
New Zealand
Nordic
Norway
Peru
Philippines
Puerto Rico
Russia
Singapore
South Africa
South East Asia
Switzerland
Taiwan
Thailand
Turkey
United Arab Emirates
Vietnam

Thanks in Advance!

For Australia refer Australian Communications and Media Authority (ACMA), Reference: Home | ACMA ...thats where the RCM/RSM complinace mark comes from!

For Canada :Industry Canada requires certification for telecommunications terminal equipment and radio devices
Reference: Compliance information - Certification and Engineering Bureau

Like Shimonv suggested do your homework and ask specific questions rather than making the forum members do the work for you!

 

[Marcelo]

IN Brazil the regulatory body is ANATEL.