• 2023-11-20 03:05:02

On October 20, Qualtech hosted a webinar titled "Korea Market Expansion and China NMPA Updates." With over 60 global participants, the event marked Qualtech's entry into the Korean market, sharing actionable steps for successful medical device registration. The second segment covered key changes in China's Medical Device regulations from September 2022 to August, ensuring attendees were informed about the latest regulatory developments.

• 2023-10-20 08:44:59

NMPA adjusted the "Medical Device Classification Catalog", involving 58 Medical Device Classifications. Among the important adjustments are strengthening the management of soft tissue ultrasound heads and breast rotary cutting products.

• 2023-07-21 03:42:44

NMPA issued <The appendix to the Medical Device Operation Quality Management Standard: Guidance for On-site Inspection of Quality Management of Enterprises Providing Medical Device Transportation and Storage Service>.

• 2023-07-21 03:04:45

The information regarding the qualified institutes for the testing according to GB 9706.1-2020 and YY 9706.102-2021.

• 2023-06-28 09:46:17

Correction action of medical devices is included in the eRPS. The structure of the online submission dossier of corrective action is provided.

• 2023-06-28 09:43:30

Center for medical device evaluation (CMDE) revised "Guidance for Registration of Intense Pulsed Light Equipment" and "Guidance for Registration of Ophthalmic Optical Instrument".

• 2023-04-25 02:06:51

GB 9706.1-2020 <Medical electrical equipment - Part 1: General requirements for basic safety and essential performance > was announced on 9th April 2020 and has been put into effect from 1st May 2023 onwards. The interpretations and relevant information are provided and have been briefly summarized in this article.

• 2023-03-27 10:02:31

The UDI of specific categories of class II medical devices is going to be implanted. In this announcement, the list of medical devices which require a UDI is provided and the relevant progress and requirements are announced.

• 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".

• 2023-01-19 06:07:49

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