Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo Especially for content not in the forum
Such as files in the Cove "Members" Directory

Indonesian MOH Regulation Restricting OEM/Private Label Medical Devices

#1
Hello All,

As we're just going through this, I'll share what I know. By way of background, we are a Thailand-based Medical Gloves manufacturer that distributes on an own-brand, private label/OEM basis, globally.

Effective 12 January 2018, an Indonesian Ministry of Health regulation (62/2017) came into effect that places limits on distributors of OEM medical devices. The stated goal of this regulation is to spur the development of the medical device manufacturing industry in Indonesia. Any devices that cannot be produced locally may only be granted a 3-year license with a single renewal period of 3 years.

Existing licenses are unaffected, except insofar as now there will only be one three-year extension available upon expiry, if after 12 Jan 2018.

There is a question as to whether this regulation is in violation of the ASEAN Free Trade Agreement, but that won't affect devices manufactured outside of ASEAN.

You may wish to advise your business if they're planning/selling into Indonesia a private-label or OEM that the business plan should be capped at 6 years if entering or for existing businesses at expiry plus 3 years.

Please also note that Indonesian regulations change rapidly and without warning so this might disappear, but I'm not going to wager on it.

Cheers!
 

Access2hc

Involved In Discussions
#2
Indonesia regulations don't change rapidly. just keep in touch with your IPAK importer frequently and that should do it.

Cheers,
Ee Bin
Access2hc
 
#3
Indonesia regulations don't change rapidly. just keep in touch with your IPAK importer frequently and that should do it.

Cheers,
Ee Bin
Access2hc
Dear Bin,

Good day! Do you have the Indonesia MDR in the English version for sharing? I am a green hand in this area. My company is planning to launch the products in Indonesia. I would greatly appreciate it if you can shall the information to me. Wish you have a lovely day!

Many thanks in advance!
Emma
 
Top Bottom