China’s NMPA Begins Issuing Registration Certificates Electronically
On October 26, 2022, the NMPA issued a notice to begin implementing electronic registration certificates for certain approved medical devices.
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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.
Beginning January 1, 2021, the NMPA began implementing UDI requirements in China for the first batch of 69 types of medical devices in 9 categories.
On June 1, 2022, the TFDA released an announcement outlining the expansion of the Singapore Reliance Route program. This allows manufacturers with Singapore approvals that used CSDT documentation to cut their review time down to 60 working days.