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More Class II & III Medical Devices Exempted from Clinical Trial

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The NMPA published the final version of “Clinical Evaluation Exempt Catalog for Medical Devices” on July 20, 2023, which includes 2025 medical devices. Implementing risk-based clinical evaluation, the catalog will make clinical exemptions more consistent with internationally accepted standards.

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 need 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 Catalog

16 types of Class III medical devices can be found in the catalog, including:

  • Breast tissue markers
  • Mobile C-arm X-ray machine
  • Tubing for continuous renal replacement therapy
  • Venous blood container
  • Cranio-maxillofacial bone plate system
  • Metal locking bone plate
  • Metal locking bone screw
  • Metal interlocking intramedullary nail
  • Sternal ligature
  • … …

Newly Exempted Devices

Compared with the 2021 catalog, fifteen medical devices are added, including:

  • Disposable intracranial retraction and fixation catheter
  • Neuromonitoring endotracheal intubation
  • Medical air compressor
  • Negative pressure assisted venous drainage controller
  • Single/multi-part prefabricated cranioplasty plates and fasteners
  • Negative pressure drainage sealing membrane
  • Surgical membrane
  • Nasal secretion electric suction device
  • Nasal hemostatic catheter
  • Contact lens care products
  • Temporary filling material
  • … …

Also, product names and descriptions for some devices are amended:

  • Sterile pipeline high frequency connection instrument
  • Cardiac defect occluder delivery device
  • X-ray contrast medium injection device
  • Contrast injection device
  • Carbon dioxide monitor
  • Medical conductive paste
  • Medical molecular sieve oxygen generation system
  • Small molecular sieve oxygen generator
  • Medical air oxygen Mixer
  • Medical air compressor
  • Metal interlocking intramedullary nail
  • Metal cables and cables
  • Non-absorbable anchor with wire
  • Sternum ligature
  • Analgesic pump medicinal reservoir
  • Infusion information collection system
  • Medical center suction system
  • Medical gas piping system – vacuum system

For an English copy of the Clinical Evaluation Exempt Catalog, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

View our service page on clinical evaluation exemptions.