• 2020-05-05 06:52:56

Due to a number of queries received from manufacturers concerning which category would their products fall under, NMPA has drafted a list of principles which aims to help applicants categorize their antimicrobial-containing medical device products.

• 2020-05-05 06:46:09

NMPA releases the registration approval power to other NMPA branch to enhance the foreign medical device access to China market. This action brings more opportunities for the foreign manufacturers to get product license and enter China market.

• 2019-11-15 03:04:06

In recent years, NMPA has mandated all applicants to manage qualification of their medical device suppliers. However, not all of supplier would like to reveal the confidential information to their customers regardless if they have already disclosed such information at the time of registration.

• 2019-11-15 03:03:19

In order to strengthen the quality control of software medical device products, the State Drug Administration has prepared the "Appendix Independent Software for Medical Device Manufacturing Quality Control Specifications (Draft for Comment)" and solicited public opinions.

• 2020-02-12 14:00:16

In early November, NMPA has issued a draft of the guideline entitled, “Biological Evaluation for Medical Device Part 1: General Principles (hereinafter referred to as “the Guideline”) and has sought comments from stakeholders.

• 2020-02-12 14:11:38

In order to encourage the development of medical devices intended for rare diseases, CNMPA has drafted a guideline whose key principles where founded on the “Opinions on Deepening the Reform of Examination and Approval System Reform and Encouraging Innovation of Pharmaceutical Medical Devices”  published by the General Office of the State Council.

• 2020-02-12 14:09:42

China National Medical Product Administration (NMPA) has revised the special approval procedures for innovative medical devices issued in 2014 to respond to current state. This revision will be effective on December 1, 2018.

• 2020-02-12 14:21:58

Last August, NMPA has issued a draft entitled “Measures for the Supervision and Administration of the Local Authorization Agent for Imported Medical Device” in order to ensure the safety and effectiveness thereof. The draft was also aimed at regulating the behavior of local authorized agents of imported medical devices.

• 2020-02-12 14:21:01

In order to reinforce the supervision and management of the development, production, operation and use of medical devices, NMPA (National Medical Product Administration) has issued the “Draft of UDI Rules for Medical Device” at the end of August with the primary objective of establishing a unique identification system (UDI) for medical devices. This regulation applies to medical devices that are sold and used in China.

• 2020-02-12 15:57:24

It is divided into 12 distinct parts, wherein the 3rd to 11th parts include technical documentations with the following main sections (a) the safety& effectiveness checklist (b) summary of the device (c) research study (d) manufacturing process, (e) clinical evaluation study (f) risk management report (g) technical requirements (h) test reports, and (i) IFU and labels.