• 2020-02-14 07:32:41

The Council decides to suspend the implementation of Clause 11 of the Medical Device Registration and Management in the Hainan tourism area. In order to support this suspension, CNDA has released a temporary Order, entitled “The Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. The scope of this Order includes all medical devices that are urgently needed for clinical purposes, operation conditions, and a

• 2020-02-14 07:37:59

CFDA has released the draft of 3D-printed medical device guidance during the last week of February. The draft guidance provides the general requirements of registration rules on 3D printed medical device.

• 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 07:35:54

International Medical Device Regulators Forum (IMDRF) held a meeting in China during March 20 to 22. The current chairman, China FDA, proposed two projects and get the support from all IMDRF members.

• 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 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