New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices?

#1
New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices?

Now as the new MDR Regulations coming into place in the EU, It doesnt sound like a strategic location for a virtual manufacturing/OEM brand for products manufacturing in china already holding a CE Mark.

As we know when a virtual brand is from Germany or UK or so, it is reputable for the global market, but now it comes with great complications with the new MDR regulations.

Can anyone suggest a global developed country which has easy regulations for an a virtual manufacturing brand HQ , to issue its certificate of origins from there , and be its location for the intellectual property rights , I am not sure really but i guess Candada, singapore, malaysia, Japan? i dont really know but can any experts advise.
 
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Murni Ahmad

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#2
Hi there,

Good questions, maybe to consider,
  1. Withholding tax for sales and service - all time
    1. Affecting selling/market price
  2. Government - short term until able to comprehend them
    1. Laws & regulation, bureaucracy
    2. Authorities especially customs, medical device
    3. Politic stability
  3. Facilities & infrastructure - long term business running
    1. Flights, ports, roads and transport, office & warehousing, location and size if it matters
  4. Manpower cost- long term
    1. Expertise, expatriate or local
    2. Language
I see most OBL coming from Australia & Singapore in ASEAN, followed by Malaysia, not far behind Thailand too.
 
#3
Hi Munir,

Up until now , it seems the best option is Singapore , in comaprison to german (which i assume is very difficult) with singapore there is the option to enter markets which only require ISO, Free sale certificate etc, then one can expand with CE,FDA for other markets.

Singapore is around 9% effective tax rate for the first 3 years, then turns into about 17% , no capital gains tax.

Strategic location, also known for ease of doing business and logistics , i think possibilty its a good option also as there ministry of health is accepting to OBL .
 

Murni Ahmad

Involved In Discussions
#4
Dear PG,

ASEAN is having the AMDD, for the "expedited" evaluation route, still need CE/FDA/TGA/HC, etc for Singapore.
Without those, you still need to go for the full evaluation route, but I don't think it's a big problem, unless you want to transit only.

But do bear in mind, AMDD in the future might also adopt some of the EU MDD, but not in the next 5-6 years' time, at least in my personal opinion.
Looking at the pattern, once Singapore started, the rest of the ASEAN will follow the trend as well. But that should be in the next 10-20 years maybe.

If the cost is not a matter, yes Singapore is a strategic choice indeed for OBL manufacturers.
For manufacturing site, might want to consider a country with more population/size such as Malaysia and Thailand.

By the way, i just realize the post is in 2020, hows your research/progress so far?
 
#5
Dear PG,

ASEAN is having the AMDD, for the "expedited" evaluation route, still need CE/FDA/TGA/HC, etc for Singapore.
Without those, you still need to go for the full evaluation route, but I don't think it's a big problem, unless you want to transit only.

But do bear in mind, AMDD in the future might also adopt some of the EU MDD, but not in the next 5-6 years' time, at least in my personal opinion.
Looking at the pattern, once Singapore started, the rest of the ASEAN will follow the trend as well. But that should be in the next 10-20 years maybe.

If the cost is not a matter, yes Singapore is a strategic choice indeed for OBL manufacturers.
For manufacturing site, might want to consider a country with more population/size such as Malaysia and Thailand.

By the way, i just realize the post is in 2020, hows your research/progress so far?
Hello Murni,

Yes , so do you think OBL registering in HSA Singapore, will benefit by allowing easiar entry into ASEAN AMDD countrys? or is this only in the future.

Regarding cost, yes as you mentioned if one needed to contract probably thailand and malaysia or china etc.

At the miniutie we do plan to setup in Singapore to begin registering 2 or 3 class B medical devices for singapore and reexport to countries that don't require CE or FDA as these can take some time.
 
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