• 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 03:57:58

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

• 2020-02-14 04:17:02

In order to optimize the efficiency of approval process, China Drug Administration (CNDA) has proposed amendments for submission documents for the renewal and clinical trial application of medical devices. This notice was issued at the end of May.

• 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 07:39:50

The Department of Industrial Policy and Promotion, Ministry of Commerce and Industry, Government of India has recently issued guidelines for implementation of Public Procurement Order No. 17 (PPO) in an aim to mandate procuring entities to make local suppliers as their priority purchase preference for medical devices,

• 2019-11-15 02:57:23

The Ministry of Industrial Policy and Promotion, the Ministry of Commerce and Industry, and the Indian government have recently issued Public Purchase Order No. 17 in order to force procurement entities to use local suppliers as the priority procurement preference for medical equipment, as well as other products and services related to the pharmaceutical sector. (PPO) guidelines.

• 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 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.