On December 9, the State Council Information Office of China held a press conference at which relevant heads of various departments introduced the relevant information of The Opinions on Strengthening the Work on Aging in the New Era“. Among them, the head of The Social Development Department of the China Development and Reform Commission said that R & D and manufacturing of elderly products will be increased，in order to guide the development of elderly industrial clusters. more…
If new mandatory standards are issued and implemented within the validity period of the registration certificate of medical devices (in vitro diagnostic reagents), and the items specified in the registration certificate and its attachments of registered products are not changed, that is, they meet the new mandatory standards, including the following two situations: more…
The new regulations on the requirements of medical device registration and declaration materials the Announcement on Publishing the Requirements of Medical Device Registration and Declaration Materials and the Format of Approval Supporting Documents (No. 121 of 2021) has been officially implemented on January 1, 2022. The new regulations on the requirements of registration and declaration materials has adjusted the content and form of medical device registration and declaration materials, the enterprise shall complete the preparation or update of registration application materials according to the new requirements. more…
In January 2018, China’s State Drug Administration issued the Technical Guiding Principles for Accepting Overseas Clinical Trial Data of Medical Devices (hereinafter referred to as the guiding principles), which clearly explained the definition, acceptance principles and requirements of overseas clinical trial data, however, in practice, how to submit overseas clinical trial data meeting the requirements of the guiding principles is still the focus of many applicants. Based on the relevant contents of the guiding principles, this paper expounds the precautions in the process of submitting overseas clinical trial data. more…
If the government purchases imported products, can the brand be specified in the bidding documents? Since the purchase of imported goods requires authorization from foreign manufacturers, whether the bidding of domestic enterprises is invalid? If the equipment purchase does not require the import of equipment, how to identify the imported equipment to bid? more…
The Administrative Measures for Registration and Filing of Medical Devices (Order No. 47) and the Administrative Measures for Registration and Filing of IVD (Order No. 48) (hereinafter the Measures) have been issued and take effective since October 1, 2021. In order to implement the related measures, NMPA published the notices on the relevant matters of technical review during the transition period. Some key issues are listed as below. more…
On Sep 27, 2021, NMPA published a new Review Guideline of Animal Studies for Medical Device Registration: Part 1 Determination Criteria (2021 Amendment) and Part 2 Animal Study Design and Conduct Quality Assurance, which have been effective since Sep 18, 2021. more…
According to the Regulations on Supervision and Administration of Medical devices (Order 739), the Administrative Measures for Registration and Filing of Medical Devices (Order 47) and the Administrative Measures for Registration and Filing of IVD (Order 48), new e-filing catalogue (eRPS) will be effective since Jan 1, 2022. more…
As a member of IMDRF (International Medical Device Regulators Forum), China is actively leading and participating in the formulation of relevant regulatory documents for international medical devices. Since 2019, NMPA has initiated to amend current China GCP (Good Clinical Practice), and in this May, NMPA collected public opinions on the draft of new China GCP. more…
