Center for medical device evaluation (CMDE) revised "Guidance for Registration of Intense Pulsed Light Equipment" and "Guidance for Registration of Ophthalmic Optical Instrument".
了解更多 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.
了解更多 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.
了解更多 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".
了解更多 In order to support the supply of antigen testing reagents for COVID-19, NMPA has made related announcements.
了解更多 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.
了解更多 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.
了解更多 NMPA supervised the product quality for various devices and found that a number of products did not comply with the requirements.
了解更多 NMPA decided to start using electronic payment for drug and medical device registration fees.
了解更多 Requirements for pre-assessment of medical device / in vitro diagnostic medical device registration are revised by NMPA.
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