supadrai
Lawyer
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!
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!