Our people came up Last week with the Idea of selling some devices in Hong Kong, for which we require device registration, as far as my knowledge is concerned, even if it is a Class I device. Though medical devices are a small part of our business, but we still have to manage with our small customer base.

But as my resources are quiet not clear, I would like to ask the forum whether we need to go through SFDA of China to sell the devices or is it good through Dept of Health (DMCO) of Hong Kong.

Second is the topic on RoHS, do we require RoHS compliance to enter Hong Kong and if so is it same as China RoHS.

It would be wonderful to hear from the forum on their views and any helpful resources where i can ask or find help.

Thank you.

krishna.

Dear krishna,

We are in Hong Kong. Hong Kong Government is working on the registration of medical device to be sold in Hong Kong but legistration work is not completed yet. As far as I know, we don't have the requirement on class I and II product set up here yet. But you'd better to check with the the "Department of Health" in Hong Kong. The Medical device control office (MDCO) is the section to look after the medical device in the department( mdco@dh.gov.hk ).

Best Regards,

Alan AU:bigwave:

Dear krishna,

We are in Hong Kong. Hong Kong Government is working on the registration of medical device to be sold in Hong Kong but legistration work is not completed yet..................................Best Regards,

Alan AU:bigwave:

Hello Alan,

Thanks for your response and thanks again for acting as our 'Hong Kong Desk'.

......................... Second is the topic on RoHS, do we require RoHS compliance to enter Hong Kong and if so is it same as China RoHS........................................... Thank you.

krishna.

Question: Is the Administrative Measure (China RoHS) applicable to Hong Kong and Macau?

Answer:

According to the Basic Law of the Hong Kong Special Administrative Region of the People's Republic of China and the Basic Law of the Macau Special Administrative Region of the People's Republic of China, the Administrative Measure is not applicable to Hong Kong and Macau. For products manufactured in Hong Kong & China and sold in the China market, they shall conform to the Administrative Measure.

A year or so ago, we (SGS UK) hosted a couple guys from the HK MoH, who had been tasked with figuring out how to develop medical device legislation for their market, so were with us on a fact-finding tour / audit.

They were very switched on, we were very impressed that they understood that they needed something both practical and effective, especially considering the size of their market.

I'm looking forward to what they eventually come up with - of course getting anything "sensible" past the politicians is of course a whole different matter! :D

Thank you Alan for your reply.

Though i share this view with you, I am sceptic about what practical difficulties would there be to enquire with the Dept of Health. If indeed i ask them, about topics like RoHS or WEEE and its applicability, my fear is that i am placing my hands in the lions den. I mean DOH offcos are not going to eat me, but i am pretty weary that just because we enquired, they want us to do everything that previoulsy was not needed.

Also our device is a basic Class I device.

Hi Harry

Its a useful info and insight from you. I presume so that RoHS, at present is not yet applicable in Hong Kong. I would inform our people with the same reply.

thanks!