News & Events

2015-06-23 Come here and download the free webinar materials on “Latest Regulatory Updates on Medical Devices in China”

2015-06-11 How to apply for and obtain the medical device registration certificate under new CFDA regulations ——Interview with Ms Cindy Fu from CIRS MD Regulatory Technical Team

2015-06-05 Graphically show you how to prepare the registration during R&D of your product

2015-05-28 CFDA Administrative Fee is here to pay, rebuild your budget

2015-05-26 CFDA publishes the guideline on technical evaluation for ER and PR antibody reagent and assay kits

2015-05-20 CFDA technical guideline on medical devices clinical evaluation

2015-05-13 Be Aware of CFDA Administrative Fee, It Is Going to Come

2015-05-12 How to conduct medical devices registration in China in cost-effective way

2015-05-07 Clinical trial activities required to be recorded in China local FDA

2015-05-05 Free Webinar: Latest Regulatory Updates on Medical Devices in China

2015-05-04 Presentations on latest regulatory updates and technical requirements for medical device are available upon request

2015-04-08 Some devices are no longer managed as class I medical devices in China

2015-04-08 Gene sequencing diagnostic related products required to register and approve in China from 9th February 2014

2015-04-06 Understanding of the medical devices competent authorities in China

2015-04-03 Which medical device can be exempted from clinical trial in China? Download the exemption list now

2015-04-01 New CFDA approval process for in vitro diagnostics

2015-03-27 CFDA asks registrant to update or renew the medical device registration certificate

2015-03-24 FAQs on medical devices registration in China are avaliable

2015-03-20 Medical Device Workshop – Regulatory insights: China, Europe and U.S.A, April 23rd, 2015 – Michelangelo Hotel, Milan, Italy

2015-03-10 Your Helpful Statistics of Medical Device Industry in 2014

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Services

CIRS China

Ms Yolanda Yan (Head office)
Tel: +86-571 8720 6559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mr. Edwin Wen (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Bryan Zhou
Tel: +353 (1)477 3710

Email: md@cirs-group.com

CIRS Korea
Mr. Junho Lee
Tel: +82 2 6347 8801
Email: md@cirs-group.com