• 2023-02-23 02:05:29

In order to supervise medical device registrants taking the responsibilities for medical device quality and safety, NMPA has issued the so-called "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety".

• 2022-09-27 07:33:24

In 2000, Qualtech was established in Taipei. Since then, Qualtech has established several locations around the world. Over the years, Qualtech has always insisted on providing high-quality medical equipment services such as regulatory consultation, product registration, clinical design and implementation, local authorized registration, and post-market surveillance. In addition to providing professional services, we also do not forget the social responsibility that belongs to Qualtech. Since Qualtech is engaged in the medical-related industry, we focus more on helping and caring for underprivileged groups.

• 2023-01-19 06:07:49

In order to support the supply of antigen testing reagents for COVID-19, NMPA has made related announcements.

• 2023-01-19 06:04:35

The NMPA drafted the <Announcement on the Third Batch of Implementation of the UDI of Medical Devices (Draft for Comment)> and is now soliciting opinions publicly.

• 2022-12-27 08:57:20

The Center for Medical Device Evaluation (CMDE) has issued the “List of Mandatory Standards Applicable to Medical Devices” for applicants to determine the mandatory standards which apply to a specific product.

• 2022-11-29 03:29:05

NMPA held a meeting to promote the implementation of the GB 9706 series standards on October 13th, 2022.

• 2022-11-29 03:18:42

NMPA supervised the product quality for various devices and found that a number of products did not comply with the requirements.

• 2022-10-25 07:28:38

NMPA decided to start using electronic payment for drug and medical device registration fees.

• 2022-10-25 07:24:41

Requirements for pre-assessment of medical device / in vitro diagnostic medical device registration are revised by NMPA.

• 2022-09-27 08:40:58

Matters concerning the filing of Class I medical devices (including Class I IVDs) are announced. The relevant documents are attached as well.