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On 23.01.2020, the Ministry of Commerce of the PRC announced (No.3-2020) the list of intermediary services and administrative examinations and approvals for import and export of goods. The China Chamber of Commerce for Import & Export of Medicines and Health Products continues to be responsible for the import quota monitoring of restricted goods in accordance
On 06.11.2019, the Central Goverment of PRC has accepted the HKSAR goverment’s proposal for the use of Hong Kong registered pharmaceutical products and common medical devices in designated Hong Kong-owned medical institutions in the Greater Bay Area. As a facilitation measure for Hong Kong residents working and living in the Greater Bay Area to seek
In accordance with the NMPA (National Medical Products Administration) publication No. 66-2019, the UDI (Unique Identification System) will be mandatory for medical devices in China as of 01.10.2019. There are currently the following two relevant guidelines: • Rules for the Unique Identification System of Medical Devices • YY / T 1630-2018 Fundamental Requirements for UDI
On 03.07.2019, the NMPA initiated the Pilot Work Plan for the “Unique Device Identification” (UDI) (No.56-2019), as announced in February 2018. The UDI mark, is made up of a combination of numbers and barcodes. It carries information about the product (i.e. identifying the license holder, the model specification and packaging) and its production (i.e. production
On 14.05.2019, the NMPA (National Medical Products Administration) updated technical review guidelines on the timeline of active medical devices (No. 23-2019). As part of the medical device registration, applicants have to verify their products’ lifespan. The lifespan describes the period in which the safe use of the product is ensured, the product can be used
On 30.09.2018, the NMPA published a revised “Clinical Trial Exemption List for Medical Devices and IVDs”, which was immediately implemented (NMPA No. 94-2018). 63 Class II and 21 Class III medical devices, 246 Class II and 31 Class III IVDs were added. The new clinic trial exemption list now contains a total of 855 medical
Funding for Testing of Medical Devices. On 17.11.2017 the NMPA (China Food and Drug Administration) published a notice announcing that fee-charging tests (also referred to as sponsored tests) are accepted as part of the NMPA registration of medical devices (No. 2017-187). In April 2017, the MOF (Ministry of Finance) had abolished most test fees for
Webinar: Opportunities in China’s Medical Device Market. Anna Fischer, Cisema (Hong Kong) Limited, gave a talk on medical device registration as part of the webinar on “Opportunities in China’s Medical Device Market” hosted by the U.S. Commercial Service on 13.12.2017. The replay is available at: https://www.mymeetings.com/nc/join.php?i=PWXW6334307&p=4709998&t=r