Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in February 2026. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
Policies
NMPA Down-Classified Delivery Guide Devices and Certain Inner Ear Prostheses
The NMPA issued the “Announcement on Adjustments to Certain Items in the Medical Device Classification Catalog” on January 4, 2026. The adjustments are aimed to keep up with the international recognized requirements and further lessen the manufacturers’ regulatory burden.
Most of the devices included in this adjustment involve revisions to the device description; three devices have been reclassified to a lower class. For certain medical devices, classification is no longer uniform but depends on specific indications. For the full list of reclassifications, please click HERE
Guidelines & Standards
Eighty NMPA Standards to be Revised in 2026: from Orthopedics and Cardiovascular Devices to Genetic and Advanced Diagnostics
NMPA issued the “2026 Medical Device Industry Standards Revisions Plan” today on January 28, 2026. One mandatory and seventy-nine recommended standards will be revised or established. The standards revisions are aimed to facilitate manufacturers with local type testing and regulatory submission and make standards more consistent with the international standards. Two English written standards in the field of genetic testing are also included in the plan. For the full list of the standards, click HERE
Priority Approvals
IVD Reagents Dominated NMPA December 2025 Reports: 8 of 10 Cases Involving Roche and Ventana Products
In the review reports released in December 2025, eight out of ten pertained to IVD reagents, reflecting the continued advancement and regulatory scrutiny in fields such as immunology and molecular diagnostics. Ventana Medical Systems secured five product approvals, while Roche Diagnostics obtained three. For our comprehensive review on the review reports, please click HERE
Featured Article
China’s New GMP for Medical Devices: What Overseas Manufacturers Need to Know
NMPA released the revised Good Manufacturing Practice (GMP) for Medical Devices on November 4, 2025, also referred to as the “Specification for Medical Device Production.” This marks the most substantial update to China’s device manufacturing regulation since the original 2014 version. The new GMP will be fully implemented on November 1, 2026.
For overseas manufacturers—even those producing devices entirely outside China—the implications are far-reaching. Registration expectations, supply chain cooperation with Chinese partners, and local manufacturing or finishing arrangements will increasingly be assessed against this updated GMP regulation.
For our analysis on the new GMP, including the introduction of newly introduced chapters on quality assurance, validation and verification, and contract manufacturing, please click HERE