NMPA published the “Clinical Evaluation Exempt Draft Catalog for Medical Devices” and “Clinical Evaluation Exempt Draft Catalog for In Vitro Diagnostics” on April 30, 2026. Feedbacks need to be submitted by May 29, 2026. It proposes to newly-include 11 Class III medical devices and 66 Class III IVDs into the exemption list. Implementing risk-based clinical evaluation, the catalog is intended to make clinical exemptions more consistent with internationally accepted standards.
24 Class II devices and 14 Class II IVDs are proposed to be added into the catalog. In total, 1080 medical devices and 573 IVDs to be exempted from clinical evaluation.
Ask us if your devices are in the catalog. Even if not, we can develop clinical evaluation strategy to help you avoid the expensive and time-consuming clinical trial. info@ChinaMedDevice.com.
How the Exempt Catalog Works
A major change between decree 739 and decree 680 is that the “Clinical Trial Exempt Catalog” is replaced by “Clinical Evaluation Exempt Catalog”. Previously, for class II and class III medical devices on the clinical trial exempt catalog, the clinical trial is not required, the applicant only needs to submit a basic CER (Clinical Evaluation Report). Now, the first thing to do when deciding the clinical pathway for China registration is to check the “Clinical Evaluation Exempt Catalog”. If the device is included in the “Clinical Evaluation Exempt Catalog”, the clinical trial is not required either. Instead of a basic CER, the applicant needs to submit the comparison document for the product to be registered:
1) the corresponding content in the catalog.
2) the predicate already approved in China.
The items to be compared include but not limited to the working principle, components, material, performance requirements, sterile/disinfection method, application scope, methods about how to use the device. Based on the comparison, if any difference between the predicate and the product to be registered, the applicant needs to justify that the difference will not lead to new risk(s) in terms of product safety and effectiveness.
The submitted comparison document needs to be able to prove that the product to be registered is essentially the same as the product in the “Clinical Evaluation Exempt Catalog”, otherwise, the applicant needs to identify and collect the clinical evidence and submit the CER together with the clinical evidence the CER is based on.
The following principles are required for a device to be on the exempt catalog：
• The working mechanism is clear.
• The design and production process are mature.
• Similar types of medical devices have been marketed and used in clinical settings for many years.
• There is no record of serious adverse events.
• The medical device is safe and effective through evidence of nonclinical evaluation.
• The analysis and evaluation of data obtained from clinical trials, or clinical use of the similar types of
medical devices, can demonstrate safety and efficacy.
Class III Devices in the Draft Catalog
The following Class III devices are proposed to be exempted from clinical trial:
- Disposable Breast Rotational Biopsy Needle
- Disposable Sterile Clamp Applier (with Non-absorbable Closure Clip)
- Disposable Peripheral Nerve Block Kit
- Oral Cavity Cone Beam CT / Oral and Maxillofacial Cone Beam Computed Tomography Equipment
- X-ray Computed Tomography Equipment (CT)
- Permanent Magnet MRI System
- Conventional Conducting MRI System
- Superconducting MRI System
- Electronic Bronchoscope
- Electronic Choledochoscope
- Oral Cavity Panoramic X-ray Machine / Oral and Maxillofacial Panoramic X-ray Machine
Class III IVDs in the Draft Catalog
- Echovirus antibody detection reagent
- Enterovirus 71 antibody detection reagent
- Herpes simplex virus type I (HSV I) antibody detection reagent
- Herpes simplex virus type II (HSV II) IgG avidity detection reagent
- Herpes simplex virus type II (HSV II) antibody detection reagent
- Chlamydia pneumoniae antigen detection reagent
- Chlamydia pneumoniae IgM antibody detection reagent
- Chlamydia pneumoniae IgG antibody detection reagent
- Mycoplasma pneumoniae antigen detection reagent
- Mycoplasma pneumoniae IgM antibody detection reagent
- Mycoplasma pneumoniae IgG antibody detection reagent
- Rubella virus IgG avidity detection reagent
- Parainfluenza virus antibody detection reagent
- Toxoplasma gondii IgG avidity detection reagent
- Toxoplasma gondii IgM antibody detection reagent
- Hantavirus (HV) antibody detection reagent
- Respiratory syncytial virus (RSV) antigen detection reagent
- Respiratory syncytial virus (RSV) antibody detection reagent
- Hepatitis A virus (HAV) antibody detection reagent
- Ureaplasma urealyticum genotyping detection reagent
- Ureaplasma urealyticum (UU) nucleic acid detection reagent
- Ureaplasma urealyticum (UU) antibody detection reagent
- Ureaplasma parvum (UP) nucleic acid detection reagent
- Mycoplasma hominis (MH) nucleic acid detection reagent
- Mycoplasma genitalium (MG) nucleic acid detection reagent
- Cytomegalovirus IgG avidity detection reagent
- Anti-parvovirus B19 antibody detection reagent
- Coxsackie virus group B antibody detection reagent
- Schistosoma japonicum antibody detection reagent
- Schistosoma egg antibody detection reagent
- Chlamydia trachomatis antibody detection reagent
- Chlamydia trachomatis antigen detection reagent
- Adenovirus antigen detection reagent
- Gardnerella vaginalis antigen detection reagent
- Trichomonas vaginalis antigen detection reagent
- Helicobacter pylori antibody detection reagent
- Helicobacter pylori urease antibody detection reagent
- CYP2C19 gene detection reagent
- CYP2C9 gene detection reagent
- CYP3A5 gene detection reagent
- IL28B gene detection reagent
- UGT1A1 gene detection reagent
- VKORC1 gene detection reagent
- ACE gene detection reagent
- ADRB1 gene detection reagent
- APOE gene detection reagent
- SLCO1B1 gene detection reagent
- Human leukocyte antigen B27 (HLA-B27) gene detection reagent
- Mitochondrial aldehyde dehydrogenase 2 gene detection reagent
- Methylenetetrahydrofolate reductase gene detection reagent
- Protein C detection reagent
- Protein S detection reagent
- Free protein S detection reagent
- Activated protein C resistance detection reagent
- Glucose-6-phosphate dehydrogenase detection reagent
- Ceruloplasmin detection reagent
- 17α-hydroxyprogesterone detection reagent
- Von Willebrand factor detection reagent
- Buprenorphine detection reagent
- Ketamine detection reagent (listed twice for different sample types, counted once here)
- Tetrahydrocannabinol acid detection reagent (listed twice, counted once)
- Codeine detection reagent (listed twice, counted once)
- Cocaine detection reagent (listed twice, counted once)
- Morphine detection reagent (listed twice, counted once)
- Methadone detection reagent (listed twice, counted once)
- Abnormal prothrombin (PIVKA-II) detection reagent
Also, there are medical devices and IVDs whose product description is changed.
For an English copy of the Clinical Evaluation Exempt Catalog, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
For our service page on clinical evaluation exempt, please click HERE