China NMPA Updates Classification of Sodium Hyaluronate Products
On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
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On November 10th, 2022, the China NMPA issued a notice regarding the classification of medical sodium hyaluronate products.
On October 31st, 2022, China’s NMPA published a Classification Catalogue adjustment for public comment.
On October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.
As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
Beginning August 1st, 2022, the Thai FDA implemented a new screening submission process applicable to almost all applications.
In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
On July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List.
Manufacturers looking to Southeast Asia to help grow their medical device sales should become familiar with the Common Submission Dossier Template, or “CSDT.”
Recently, the CMDE published draft Guidelines for Registration and Review of Medical Device for the following devices in June.
In March of 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) released new guidance pertaining to registering medical device software in China.