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2025 China NMPA Bluebook is here:
On June 10, 2021, the NMPA issued the “Guideline of Shelf-life for Passive Implantable Medical Device”, directing type testing and regulatory submission for wide range of non-active implantable devices. Batch-to-Batch
The NMPA is now seeking comments to the draft guidance “Artificial Intelligence Medical Software Classification ”, due by May 3, 2021. AI technologies have the potential to transform health care
The article below provides comprehensive technical review on AI-aided Software Guideline, released in June 2019. It was written by Elisa Mark and published on BioWorld, a Hong Kong-based biotech magazine,
The NMPA officially published the first guideline specifically for CDx reagents, the “Guideline for Technical Review and IFU Update for Oncology CDx Based on the Same Group of Therapeutic Drugs”
The NMPA published “Guidelines Revisions for 22 Class II Medical Devices” on March 17, 2021. Feedback needs to be submitted by April 17, 2021. It is responding to the “2021
NMPA issued the “2021 Medical Device Guidelines Revisions Plan” on February 9, 2021, in which 51 guidelines are affected. The revisions are aimed to facilitate manufacturers with local type testing
The NMPA IVD guidelines included five updates on January 19, 2021. The guidelines are put in place to guide manufacturers for local type testing, clinical trials, and regulatory approval. For
The NMPA published twelve guidelines on December 9, 2020. Among all the guidelines, seven of them are for IVD products and five are for nomenclature. The guidelines were put in