• 2020-02-14 04:16:15

During the end of May, the CNDA redefined the management and classification of the intense pulsed light device (hereinafter referred to as "IPL devices") which is intended for hair removal. This kind of IPL device is now classified under Class II medical devices, with the amended classification code: 09- 03-04.

• 2020-02-14 04:15:34

MDCO will conduct a trial to study the feasibility for Local Responsible Persons (LRP) to demonstrate that their medical devices conforms with Hong Kong requirement by using marketing approvals obtained from the China Food and Drug Administration.

• 2020-02-14 04:05:14

This month’s updates include the "Internet+Medical Health", “the Special Approval Procedure for Innovative Medical Devices”, “the Revision Plan of Medical Device Standards” among others. All information you need to know has been put in a nutshell:

• 2020-02-14 07:33:58

Large medical equipment is a special type of medical equipment with complex technology, large capital investment and high operation cost, having a great impact on medical expenses. In order to optimize the allocation of large medical equipment in the hospitals,

• 2020-02-14 07:33:20

In order to support the development of medical devices urgently needed for clinical purposes (hereinafter referred to as "emergency devices"), such as “for life-threatening cases, or diseases that may endanger public health, CMDE has released a draft of the basic principles of medical devices urgently needed in clinical purposes that may be conditionally approved to accelerate medical device listing.

• 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 The draft guidance provides the general requirements of registration rules on 3D printed medical device.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.