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The Mini-MD, ISO13485 workshops, and Product Commercialisation: Life After the Prototype Ogan and Ee Bin spent the week of February 20-24 – right towards the tail end of summer in Auckland, New Zealand, to deliver the Mini-MD, the ISO13485 workshops, and a couple of lunchtime sessions on product commercialisation. With generally clear skies and temperatures between 17-25 degrees

HIDAS (Healthcare Industry Development Association across the Strait) furthers the years of connectivity and relationship with partners across the Strait and extending that to the ASEAN region. HIDAS organised a APAC market-entry focused event on in Oct 2016, to bring to gether HIDAS member spanning from government, academia, industry, investors, and overseas partners. Much knowledge sharing was

A few days ago, people visited the CMDE (Center for Medical Device Evaluation) as usual to consult saw a notice, which says:   “With effect from today, the public consultation session every Thursday for the industry is closed, and online consulting to be officially open to the public in accordance to the Management Specification on

On January 9, 2017, the CFDA rejected 7 registration applications, in addition to the 3 other applications rejected on 3rd January, 2017 In accordance to Article 39 of Measures for the Administration of Registration of Medical Device (Decree of CFDA No.4), the following shall not be registered: If the product development carried out by the applicant and its

As 2016 comes to an end, how about a summary of the product licensing status for medical devices in China?   A brief description of the registration situation of domestic & imported medical devices this year The number of registered imported products is less than that of returned products and the number of registered domestic products

On March 17, 2016, the CFDA has consecutively issued 7 notices of personnel appointments and dismissals, and the details are as follows: Appoint Liu Pei as the Director of the Department of Medical Device Supervision with a one-year probationary period.   A bit more about Liu Pei, Curriculum vitae:   Liu Pei officially served as the

On March 11, 2016, the CFDA has released its first issue (nine in total) of national medical device quality announcement, which published the results of quality supervision sample tracking test of 703 batches (sets) of products of 25 types such as metallic bone plates, infant incubators and therapeutic respirators.   The following cases which failed