On September 17th, IMDRF, the International Medical Device Regulators Forum, has passed the proposal of Medical Device Clinical Evaluation, with unanimous approval of the IMDRF members. This proposal is written by Medical Device Clinical Evaluation Working Group, which is led by China NMPA.
More In the past weeks, Qualtech has participated in the following three events: MEDICA in Germany, the Design of Medical Device Conference in Shanghai and the OMETA Seminar in Osaka.
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Registration form regarding the Competency Development for Medical Device Manufacturing in accordance with Announcement will be hosted by Medical Device Control Division, Food and Drug Administrative.
More It is honor for Qualtech to receive an invitation from Hujing College, USST for the program ‘Training and Exchange of Precision Medical Innovation Technologies under the Background of Comprehensive Health’ in Shanghai, China from 25th November to 8th, December 2019.
More We are happy to announce the opening of our Qualtech USA (QTU) office. The office is located in South Pasadena, California.
More In accordance to the Announcement Injectable Hyaluronic Acid for Skin Correction is classified as medical device to be licensed and will be implemented in March 2019.
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The OMETA Seminar is back in 2019, to give those interested the tools to evolve and accelerate their business.
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PFDA starts to iron out flaws ahead of the upcoming implementation of AO 2018-0002. Things to keep an eye out for are the new guidelines for risk classification, separate scope for refurbished medical devices, guidelines and process of securing licenses for local medical products.
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There is a lack of order and strong regulations in the procurement of medical consumables. China’s government has therefore issued measures to stabilize the currently chaotic situation.
More The regulations of examination for testing institutions in China have been changing for the past 2 years. Currently the State Administration for Market Regulation (SAMR) plans to re-organize the structure of testing centers, from solely permitting official institutions to now also opening up the procedure to public 3rd-party testing organizations.
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