NMPA Center for Medical Device Evaluation Issues 57 Medical Device Registration Review Guidelines (2026 No. 24)

On July 21, 2026, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) officially released 57 medical device registration review guidelines, including the Guideline for Registration Review of Magnetocardiograph Signal Acquisition Equipment.

This comprehensive release covers a wide spectrum of medical device categories:

l Active Medical Devices: Magnetocardiograph signal acquisition equipment, telemetry monitoring systems, surgical microscopes, insufflators, electronic colposcopes, tonometers, laryngoscopes, surgical power devices, electric hospital beds, electric operating tables, electric gastric lavage machines, pulse oximeters, patient temperature management devices, etc.;

l Non-active Surgical Instruments: Sterile ophthalmic surgical instruments, endoscopic curettes, surgical dissectors, disposable umbilical cord scissors, hemostatic bandages, neonatal oxygen hoods, anesthesia reservoirs, single-use laryngeal masks, etc.;

l Dental Devices: Dental implant planning software, custom orthodontic appliances, dental implant guides, temporary crowns/bridges, glass-ceramic blocks for dental prosthetics, dental handpieces, zirconia ceramic blocks, custom dental prosthetics, etc.;

l In Vitro Diagnostic Reagents: Lactate assay reagents, carbamazepine assay reagents, digoxin detection reagents, valproic acid assay reagents, carbon dioxide assay reagents, N-acetyl-β-D-glucosaminidase detection reagents, adenosine deaminase assay reagents, platelet analyzers, etc., along with 2026 revised editions of multiple reagents (ALT, homocysteine, insulin, C-peptide, D-dimer);

l Others: Medical molecular sieve oxygen systems, cryoanalgesia devices, tongue diagnosis instruments, same-type clinical evaluation of medical dressings, bone cement cannula components, external orthopedic fixation devices, etc.

Among these, 30 are revised guidelines, reflecting systematic updates to previously issued technical documents.