Regulatory Open Forum

I am trying to clarify a few points about Class II medical devices in China and Hong Kong.

1. Registrations in China from outside of China go through the national regulator NMPA but domestic made devices can go through a regional regulators office. Our situation is:
   • The device legal manufacturer is in the EU but main component is made in a Chinese facility of an EU sub-contractor. The Class I component is made in the EU at the LM site. Can we go through the domestic channel for registration and keep the LM in the EU or will the LM need to be the China based EU owned sub-contractor. Please note that both parts can the made in China or the Class I component added to the finished product.
2. Hong Kong.
   • Can you transfer a registration between Sponsors/importers?
   • Has anything moved forward on the Greater Bay project which was foreshadowed last year.
   • If it has gone ahead, does it still only apply to HK owned medical facilities or has it evolved into general approval to sell devices.

Thanks and regards


Barry

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Barry Evers-Buckland
Director
Eltham North VIC
Australia
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Regarding your question about Class II medical devices in China. Here are 3 key points need clarifying.

1. Where do you assembly/manufacture the finished products? If in China, it could be registered through domestic channel.
2. What technique processes does the finished product manufacturer do? If the major parts are done in China, it could still be registered through domestic channel, even though some simple work, like final testing, is done in EU. 
3. The LM has to be the Chinese facility and make sure it has the production license of medical device. 

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Raymond Ng
China Regulatory Affairs
Accestra Consulting
China Regulatory Outsourcing for Food & Drug for NMPA/CFDA registration of China Drug: NDA/IND/DMF/APIs www.accestra.com
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Original Message:
Sent: 21-Sep-2021 23:59
From: Barry Evers-Buckland
Subject: China and Honk Kong

I am trying to clarify a few points about Class II medical devices in China and Hong Kong.

1. Registrations in China from outside of China go through the national regulator NMPA but domestic made devices can go through a regional regulators office. Our situation is:
   • The device legal manufacturer is in the EU but main component is made in a Chinese facility of an EU sub-contractor. The Class I component is made in the EU at the LM site. Can we go through the domestic channel for registration and keep the LM in the EU or will the LM need to be the China based EU owned sub-contractor. Please note that both parts can the made in China or the Class I component added to the finished product.
2. Hong Kong.
   • Can you transfer a registration between Sponsors/importers?
   • Has anything moved forward on the Greater Bay project which was foreshadowed last year.
   • If it has gone ahead, does it still only apply to HK owned medical facilities or has it evolved into general approval to sell devices.

Thanks and regards


Barry

------------------------------
Barry Evers-Buckland
Director
Eltham North VIC
Australia
------------------------------