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2025 China NMPA Bluebook is here:
NMPA Regulations for AM Medical Devices NMPA places high importance on the regulation of 3D-printed medical devices. Custom AM implants typically fall under Class III high-risk devices and are subject
Additive Manufacturing (AM), or 3D printing technology, is triggering a profound technological revolution in the global orthopedic field. With its personalized, precise, and rapid manufacturing capabilities, 3D printing is now
The NMPA granted Innovation Approvals to two pieces of equipment in April 2022: Radiology: Magnetic resonance imaging system Orthopedic: Hip replacement surgery navigation and positioning system NMPA issued the list
The NMPA issued the “Optimizing Mandatory Standards for Medical Devices (Draft)” on January 5, 2022 for feedback. Feedbacks need to be submitted by February 10. The document lists 458 standards,
The NMPA published the “Catalog of Medical Devices Prohibiting of Entrusted Production” on November 17, 2021, providing the scope of 22 devices which are not allowed for contract manufacturing. NMPA has introduced the MAH
NMPA published six guidelines in August 2021: Guideline for Safety and Effectiveness Evaluation of Medical Devices Using Nanomaterials Part 1: System Framework Guideline for Nomenclature of Nerve and Cardiovascular Surgical
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