• 2020-02-14 07:36:53

The state council of China issued a cabinet report during the congressional sessions in March. China government plans to reform many agencies and establish a new administration, market supervision administration. The affected agencies include the State Administration of Industry & Commerce,

• 2020-02-14 07:34:46

Medical device regulations in China have changed frequently in the recent years, such as updating of multiple national standard andindustry standards, issuing of product guidance and administrative directives. With its 10-year experience in China's active medical device registration,

• 2020-02-14 07:50:54

The Unique Device Identification (UDI) system is a set of alphanumeric codes that serves to enhance monitoring activities for medical devices. It consists two parts: (1) UDI (an array of alphanumeric codes) and (2) UDI carrier which come in three distinct types: (a) QR code, (b) Bar code, or (c) RFID/NFC.

• 2020-02-14 07:50:05

The applicant may initiate the cancellation of the registration license of imported medical equipment to CFDA. This administrative application will not charge any application fee. The applicant shall prepare the submission documents to cancel the application. The CFDA will conduct a formal review on the cancellation application.

• 2020-02-14 07:47:54

The Guidelines released by the Department of Health concerning Medical Device Registration is in place to be officiated following its publication. This shall be implemented a year after its effective date. Delayed implementation allows sufficient preparation for applicants in securing technical documents crucial to the registration process.

• 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 14:55:31

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.