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Expand Into China‘s Medical Device Market

30/08/12 - 31/08/12

China State Food and Drug Administration (SFDA) is the regulatory body that governs and oversee that all healthcare products are safe for used before it is allowed to be supplied to consumer.

More suppliers, both local and foreign, of healthcare products are finding ways to enter into China market. The contributing factors for the suppliers to do so are the increase in affluence and booming demands for better quality healthcare products.

Understanding the SFDA Regulatory framework and submission of application for pre-market product registration can be challenging.

Dr Song Xin Hua from Shanghai was especially invited to conduct “China SFDA Regulations and Product Registration Seminar and Workshop For Medical Device”. This is the first time that such a seminar cum workshop being on “China SFDA Regulations and Product Registration Seminar and Workshop For Medical Device” is held in Singapore. This was jointly organised by Singapore Manufacturers’ Federation (now Singapore Manufacturing Federation) and DH RegSys and supported by SGS Systems and Services Certification.

Ms Lee Lai Mei, Business Development Manager of SGS Systems and Services Certification kick off the seminar with her presentation “An overview on the growth of Medical Devices Globally”.

Though Dr Song delivered the seminar in Mandarin, Ms Tan Hwee Ee, Principal Consultant of DH RegSys was at the seminar to assist with translation to English. Hence, participants who are not as conversant with Mandarin were still able to appreciate and understand the information given that translation to English was provided.

The participants are mainly from Regulatory Affair functions and working for various medical device manufacturers. Some participants are also not from manufacturers/product owners, but from contract manufacturers and logistics industry.

The feedback from participants at the end of seminar had been most encouraging. Participants find the seminar to be educational and effective. More importantly, participants were able to clear any doubts that they may have prior to attending the seminar cum workshop.



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