• 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 15:56:38

The National Medical Product Administration (hereinafter referred to as NMPA) has released a list of medical device industry standards covering the new and amended standards from August 7th. Notable standards included in this exhaustive list, among others, include "Electrical safety standards for medical electrical equipment",

• 2020-02-12 15:55:53

On August 29, a new notice from the department of drug registration has revealed that CFDA has changed to its official English name to ‘National Medical Product Administration (NMPA)’ which was also adopted by the medical device registration system. It can be seen that NMPA is already an officially recognized English name.

• 2020-02-14 04:02:32

Large medical equipment is a special type of equipment with complex technology, large capital investment and high operational cost, creating a great impact on medical expenses. This April, China government has issued “The New Acceptance Catalogue for Large Medical Equipment”.

• 2020-02-14 04:01:45

The Hainan Government has issued “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”, which shall be applicable for the importation and approval of medical equipment urgently needed in the clinical setting.

• 2020-02-14 04:00:29

In order to enhance the requirements for clinical trial approval for non-active implantable medical devices, CNDA has issued “the Guidelines for the Submission Documents of Clinical Trial Application for Non-active Implantable Medical Devices” (hereinafter referred to as the Guideline) in June.

• 2020-02-14 03:59:43

In early June, CNDA had issued a draft consisting of the fourth batch of medical device catalogues to be exempted from clinical trials along with the revisions of the first three batches of catalogues, in able to catch up with the upcoming classification to be implemented in July. In this regard, CNDA is currently accepting comments from the public until the end of June 2018.

• 2020-02-14 03:58:45

In order to optimize the evaluation system of medical device and encourage the innovation of medical equipment, the Ministry of Justice of China has drafted some changes on Regulation on the Supervision and Administration of Medical Devices. This draft is open for public comments until July 24.

• 2020-02-14 03:57:58

CNDA welcomes public comments on the recently drafted policy entitled, "Principles of the Clinical Trial Inspection for Medical Devices", hereby referred to as "Principle".

• 2020-02-13 06:12:14

Taiwan Food and Drug Administration(TFDA) is organizing an upcoming seminar in end of July (July 20th, 2018) in Taoyuan (Taiwan), and Qualtech has been invited to share our GCP experience in China. This seminar will discuss the GCP inspection of medical devices in various oversea countries and how to conduct a multicenter clinical trial in various countries.