China's NMPA CMDE Releases Five New Registration Review Guidelines for Medical Devices
In a bid to enhance the standardization of registration applications and technical evaluations for specific medical devices, the NMPA CMDE in China has unveiled five new registration review guidelines. These guidelines aim to streamline the registration process and ensure thorough technical evaluations for medical devices originating from various sources.
The newly released guidelines cover a diverse range of medical devices, including Monkeypox Virus Nucleic Acid Test Kits, Corneal Topography Devices, Laparoscopic Surgical Systems (including decision-making and requirements for animal experiments, as well as three-dimensional endoscopy), and Medical Device Optical Radiation Safety. These guidelines are designed to provide clear criteria and requirements for the registration review process, ensuring consistency and efficiency in evaluating medical devices.
By the end of 2023, the total number of effective guidelines has reached 613, significantly expanding the coverage of China's medical device classification catalog.
If you would like to learn about the guiding principles related to your products in China, please feel free to contact me at contact@txcro.com.