REGULATION
NMPA Announcement on Issuing the Guidance for the Preparation of Annual Self-inspection Report of Medical Device Quality Management System
In order to strengthen the supervision over medical device manufacturing and guarantee the safety and effectiveness of medical devices, according to Paragraph 2 of Article 35 in the Regulations on Supervision and Administration of Medical Devices, the Nati...
Provisions for Administration of Medical Device Recall
(Promulgated by Decree No. 29 of the China Food and Drug Administration on January 25, 2017, these Provisions shall be effective as of May 1, 2017.)...
Provisions for Supervision and Administration of Medical Device Manufacturing
(Promulgated by Decree No. 53 of the State Administration for Market Regulation on March 10, 2022, these Provisions shall be effective as of May 1, 2022.)...
Provisions for Supervision and Administration of Medical Device Distribution
(Promulgated by Decree No. 54 of the State Administration for Market Regulation on March 10, 2022, these Provisions shall be effective as of May 1, 2022.)...
NMPA Notice on Matters Concerning the Registration of Drug-device Combination Products
With the view to strengthening registration management of drug-device combination products, in accordance with relevant provisions for registration management of drugs and medical devices, matters concerning the registration of drug-device combination prod...
NMPA Announcement on Implementing Relevant Matters of the Regulations for the Supervision and Administration of Medical Devices
The revised Regulations for the Supervision and Administration of Medical Devices (State Council Order No. 739, hereinafter referred to as the Regulations) will be implemented as of June 1, 2021. NMPA is organizing the formulation and revision of supportin...
NMPA Announcement on Issuing the Working Procedures for Dynamic Adjustment of Classification Catalogue for Medical Devices
In order to strengthen the classification management of medical devices and standardize the dynamic adjustment of the Classification Catalogue for Medical Devices, according to the Regulations for the Supervision and Administration of Medical Devices and t...
National Annual Report for Medical Device Adverse Event Monitoring (2020)
Overall Situation of National Annual Report for Medical Device Adverse Events In 2020, the National Medical Device Adverse Event Monitoring Information System has received a total of 536,055 reports of medical device adverse events, showing an increase of...
Requirement for Instruction for Use and LABEL
In order to regulate the specifications and labels of medical devices and ensure the safety of medical devices, these Regulations are formulated in accordance with the regulations on the supervision and administration of medical devices. ...
Medical Device Product Registration Fee
For Class II and Class III product, CFDA charges the Registration Fee, Extension Fee, Registration Change Fee, and Clinical Trial Permission Fee as below ...
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