• 2020-02-14 14:45:04

"The Guidelines for Accepting Overseas Clinical Data of Medical Devices" (hereinafter referred to as the "Guideline") was promulgated last January 11, 2018. CFDA has declared that they will be accepting overseas clinical trial data of devices registered in China.

• 2020-02-14 14:44:06

The CFDA has approved "The Administration Regulation for Online Medical Device Sales" (hereinafter referred to as the “Regulation”) proposed last November 7 2017, and will be fully implemented on March 1 2018. A total of 50 Clauses, including legislative purposes and scope, are outlined in the Regulation.

• 2020-02-14 14:43:01

Medical device standards are a unified basis for the development, production, operation, use and management of medical devices. These are also important indications of the development of medical device industry.

• 2020-02-14 14:56:10

Fast-growing the medical device market is by reading the domestic medical device manufacturing sector growth. In first-half of 2017, it grows 12.6% comparing to 2016 with total revenue at 142 billion RMB, according to Ministry of Industry and Information Technology of China

• 2020-02-14 14:55:31

In line with the rapid development of cloud computing, big data and artificial intelligence, mobile technology has been widely used in medical devices. Recently, China Food and Drug Administration (CFDA) released “Guidelines of Mobile Medical Device Registration." The provisions of this guideline was implemented from its effective date on December 29th, 2017.

• 2020-02-14 14:54:42

In order to enhance the inspection of imported drugs and medical devices, China Food and Drug Administration (CFDA) has issued “Draft of Regulations for The Administration of Overseas Inspection of Drug and Medical Devices”. It is currently looking for public comments until January 24, 2018.

• 2020-02-14 14:54:11

Before undergoing registration application in China, medical devices shall be sent to medical device inspection agencies for examination to ensure that the products meet national standards. CFDA has issued a notice on the examination work to ensure the efficiency of registration of medical devices. The details of the notice are as follows:

• 2020-02-14 15:23:25

On November 14th 2017, Center for Medical Device Evaluation (CMDE) released "The Draft of the Guidance of Accepting the Overseas Clinical Trial Data for Medical Device", which is applicable to medical devices (including in vitro diagnostic reagents, IVDs).

• 2020-02-14 15:22:02

The Clause 29th of "The Guidance of Registration for In-vitro Diagnostic Reagent” clarifies that for in-vitro diagnostic (IVD) reagents exempt from clinical trial, the applicant is responsible for the evaluation of the clinical performance of the IVD reagents by means of evaluating the clinical samples from the intended use, interference factors, comprehensive literatures and other pre-clinical data.

• 2020-02-15 06:21:59

In order to improve the design of clinical trials of medical devices in the country, the Center for Medical Device Evaluation (CMDE) drafted the guidelines for the design of clinical trials of medical devices, and asked for the public’s opinion.