HSA Medical Devices Cluster (MDC) shared a draft guideline for the regulation of Laboratory Developed Tests (LDTs). The regulation’s scope includes laboratories that develop In Vitro Diagnostic (IVD) devices. HSA requests stakeholders to provide comments for further discussion.
More The Center for Medical Device Evaluation (CMDE) has formulated “Technical Guidelines for the Compliance of the <Basic Principles of Medical Device Safety and Performance>".
More China's National Medical Products Administration (NMPA) has issued guidance on nomenclature of generic name for 6 subcategories.
More 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.
More NMPA has organized and revised the “Guidelines for the Compilation of the Annual Self-Inspection Report of Medical Device Quality Management System”, which has been promulgated and shall come into force on May 1, 2022. The Guidelines for the Compiling of the Annual Self-Inspection Report of Quality Management System of Medical Device Manufacturers issued by NMPA (No. 76 of 2016) previously shall be abolished at the same time.
More NMPA has released a series of updated guidelines, which aim to guide registration applicants to prepare for medical device software and AI medical device registration in China. The 3 new guidelines regulate the technical reviewing requirements of medical device software and AI medical devices, while also elaborating on standardizing the cyber-security for medical devices.
More NMPA has released the latest guidelines, which aim to guide registration applicants in the preparation and writing of passive implantable medical device stability research and registration application materials. While it further also provides a reference for the technical review departments.
More Software as Medical Device (SaMD) is rapidly developing and frequently updating its compatible hardware. In order to ensure the safety, performance, and quality of SaMD while keeping in line with international standards, TFDA has released a guideline regarding post-market change application of SaMD.
More This guideline applies to medical devices including in vitro diagnostic reagents applying for registration or filing with NMPA in China. This guideline only provides general requirements for the format and content of the product technical requirements (PTR) for medical devices and does not specify specific requirements for certain products.
More Drug-device combination products that mainly function as medical devices (referred to as drug-device combination medical devices in this guideline) are expected to make prevention and treatment of diseases more effective, but may also lead to new technical concerns. Therefore, NMPA formulated two guiding principles to further guide the applicant's preparation for the registration application for drug-device combination medical devices, and to encourage the innovative development of such products.
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