• 2024-03-01 08:34:44

This guidance clarifies the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices.

• 2023-09-27 07:45:33

NMPA revised the Catalog of Medical Devices Exempt from Clinical Evaluation (2021) and published the Catalog of Medical Devices Exempt from Clinical Evaluation (2023).

• 2023-06-28 09:38:06

This document aims to ensure that the summary of the clinical investigation report presents information about the design, conduct, analysis, and results of the clinical investigation in terms and in a format that are easily understandable to the intended user of the medical device.

• 2023-05-30 02:10:17

1. Qualtech is Part of Your Team

Given the constantly changing medical device regulatory environment, Qualtech is ready to be an essential part of your RA team. That is, we provide you with one-stop services to navigate you through the different global markets and to expedite your regulatory approvals in your target countries.

• 2022-11-29 03:08:35

The document sets out frequently asked questions and their answers regarding the implementation of the rules on clinical trials.

• 2022-08-30 02:59:24

China's Center for Medical Device Evaluation (CMDE) has released recommended paths for clinical evaluation for a number of products, which fall in the subcategories 01, 04, 07-10, 19, as well as 21 of the Category of Medical Devices.

• 2022-07-26 11:00:06

China's Center for Medical Device Evaluation (CMDE) has released recommended paths for clinical evaluation for a number of products, which fall in the subcategories 02, 03, 05, 06, 16, 18, as well as 20 of the Category of Medical Devices.

• 2022-07-26 09:41:26

The TGA has released version 3.1 of its latest guideline for the clinical evidence for medical devices. The purpose of this guideline is to allow both industry and TGA to support sponsors and manufacturers to collect, compile and present clinical evidence under regulatory requirements as well as to inform on how TGA assesses clinical evidence.

• 2022-06-29 02:03:22

China's Center for Medical Device Evaluation (CMDE) has released recommended paths for clinical evaluation for a number of products, which fall in the subcategories 11-15, 17, as well as 22 of the Category of Medical Devices.

• 2022-05-26 13:08:24

NMPA, in conjunction with the National Health Commission, has revised the Quality Management Practice for Clinical Trials of Medical Devices, which is hereby promulgated and will take effect from May 1,2022.
Attachment: Quality Management Practice for Clinical Trials of Medical Devices