On December 25, 2019, the NMPA issued the so-called "Guideline for General Naming Rules for Medical Devices" (hereafter simply referred to as the “Guideline”), which is based on the "Medical Device Common Name Naming Rules". The Guideline is formally implemented from now on, and is applicable to medical devices only, not including IVDs.
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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. Diversity group of trainees consisted of innovators and professors from Brazil, South Africa, Israel, and Singapore, where Qualtech ASEAN represents Malaysia and Thailand.
More Recently on November 13, NMPA had issued a notice on the suspension and rectification of a domestic manufacturing factory,, instructing the manufacturer to stop production until rectification is completed and approved by NMPA. On the other hand, nearly 30 manufacturers (domestic and foreign) initiated voluntary recalls of their products in November. Similar news has been cropping up in recent year, and it’s foreseeable that NMPA will keep strengthening the surveillancein the future.
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 Through efficient teamwork and an outstanding cooperation, Sunmax and Qualtech obtained the first approval for Sunmax’s collagen facial implant product in China in the year 2014.
More Qualtech will discuss the latest trend of medical device regulations and share the latest information of China’s regulation in overseas medical device regulation seminar on December 13th, 2019, in Osaka.
More 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 In the recent years, CMDE has started to adjust the internal workflow to optimize the registration process. In 2015, they have changed the structure of the reviewing department. This time, they have set up two different departments for a faster operation.
More The NMPA has issued the first global regulatory on the lifetime of active medical devices. This guideline provides various aspects on lifetime evaluation, and all manufacturers producing active medical device should carefully regards this specific issue.
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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