The new Silk Road – One Belt, One Road

Rollercoaster in regulatory science, that is perhaps how I could best describe the road to regulatory compliance in China for medical devices. Since the publication of the new Bill 2014, numerous laws and rules on further implementation details have been added. Much more focus on clinical data, risk-focus approaches, Addition of a UDI system, more attention to consistency in dossiers, and more emphasis on the players supporting the manufacturers, such as the China agent.

Looking at the developments in the EU-MDR and EU-IVDR, one can see a great many elements overlapping. The key difference being the slow process of legislation and the long transition periods we see in Europe, whilst top speed is what drives the implementations in China.

The authority is also quickly adding resources, for local inspections of various stakeholders, and for foreign manufacturer audits, typically bringing 4-5 inspectors to your facility. And as they are different from the QSIT, ISO 13485 and MDSAP audits, we see a fast uptake on the CFDA mock inspection services. 

More changes are expected to come. On the one hand, the continuation of additional regulatory requirements. And on the other hand, we might see an effect on the structure inside the authorities where reorganizations are being prepared.

On April 5th it is Tomb Sweeping day in China. A day to look back into the past, remembering what you’ve learned from your predecessors. A moment of contemplation, looking backwards, but also directed at the future. To give you more energy and inspiration to move on and accept and embrace the chances and challenges ahead of you! 

In this newsletter you will find some highlights, and it is well recommended to follow the free webinar from our China team on April 10, 2018. (Have you not subscribed to our newsletter yet? Subscribe here and we will keep you up to date!)

Should after reading and/or listening you want to know more, then by all means, get in touch with me or the Qserve China team. Following Chinese traditions, we’re always happy to talk and support!

With kind regards,



Gert W. Bos, PhD, Fraps
Post date: April 04, 2018
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