2025 China NMPA (CFDA) Bluebook

This 160+ page guide outlines regulatory changes to Product Registration, Clinical Evaluation, Post Market Compliance, Quality Management System and Manufacturing requirements:

• On August 28, 2024, the NMPA released the “Law of the People’s Republic of China on the Administration of Medical Devices (Draft for Public Comment).” Feedback had to be submitted by September 28, 2024. For the first time that China NMPA regulation for medical devices has been elevated to law level from regulation since Decree 739. This shows China intends to increase its medical device development and the quality level.
• NMPA issued the “Draft Classification Catalog for IVD Reagents” on March 14, 2023, and finalized it on May 11, 2024. The new Catalog is the result of several years of effort to standardize the classification and streamline the IVD registration process.
• The NMPA published the “Announcement on Standardizing the Classification of Medical Devices” on May 11, 2024. NMPA will implement these new rules from September 1, 2024.
• From April 1, 2024, certain aesthetic devices are classified as medical devices. As a result, they shall not be produced, imported, or sold without obtaining a medical device registration certificate.
• NMPA published the “Guideline on Core Raw Materials of In Vitro Diagnostic Reagents” on January 3, 2024, along with eleven IVD related guidance.
• NMPA published the “2024 Medical Device Guidelines Revisions Plan” today on April 11, 2024, in which 49 guidelines for Class III and 60 for Class II devices are affected.
• NMPA issued the draft version of “2024 Medical Device Industry Standards Revisions Plan” on March 22, 2024, with the deadline for feedback on March 29.
• The NMPA released the “Announcement on Further Clarifying Matters Related to the Domestic Production of Imported Medical Devices in China (Draft)” on November 4, 2024. The guideline introduces changes to the rules governing foreign-invested enterprises (FIEs) involved in producing imported medical devices domestically in China. This draft is an update to the initial regulation released in 2020 (Decree 104).
• In 2024, the NMPA issued 149 review reports covering a wide array of medical devices from cardiovascular to orthopedic, involving companies like Medtronic and Siemens.
• As of December 25, 2024, the NMPA has approved 315 innovative medical devices for marketing, of which 65 were approved in 2024, 18 of them are import products.
• NMPA published the “Management for Temporary Importation and Use of Medical Devices Urgently Needed in Clinical Settings” on July 19, 2024. It greenlights the urgent importation and use of medical devices nationwide even if they have not been approved by NMPA.
• NMPA published the “Clinical Evaluation Exempt Catalog for Medical Devices (Draft)” on July 31, 2024, which newly-includes 23 medical devices.
• NMPA published the “Clinical Trial Exempt Catalog for In Vitro Diagnostic Reagents (Draft)” on November 5, 2024, which newly-includes 387 IVDs.
• “Quality Management Practice Specification for Clinical Trials of Medical Devices ( China GCP)”, implemented in March 2022, specifies that “Clinical trial sites must be on the NMPA filed institutions list for Medical Device Clinical Trial Sites”.
• NMPA published the “Inspection Checkpoints and Judging Principles for Clinical Trial” for feedback. Feedback needs to be submitted by June 30, 2024.
• NMPA released “Quality Management Measures for Medical Device Operations” on December 7, 2023, effective July 1, 2024. The previous version published in 2014 was obsolete.
• Key highlighted areas include comprehensive review and implementation of “Made in China Policy”, reviewers’ opinion on PD-L1 Screening Assay Registration, registration approach to SaMD products, overview of China Registration and Development Status of Pediatric IVD Reagents, Regulatory Approval of Innovative Neurosurgical Medical Devices—Focusing on Preclinical and Clinical Trials.