Bryan Gilburg - China

Albert Pranoto

Director of Business Development, Asia Actual Singapore

“The regulatory barriers in China have been significantly reduced for these 47 devices.” 

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China NMPA Adds 47 Products to Clinical Trial Exemption List

Published on: August 22nd, 2023

On July 24, 2023, China’s National Medical Products Administration (NMPA) updated its clinical trial exemption list, adding 47 products. The NMPA updates this list every two to three years, with the last amendment in 2021. There is some indication that this latest update could also signal a change to the China Medical Device Catalogue in the coming months, which our experts are watching carefully.

You can view the updated NMPA clinical trial exemption list in its original Chinese here. We’ve included a version translated into English here. You can view the official announcement regarding the update here.

Importance of the Clinical Trial Exemption List in China

Foreign manufacturers that are interested in introducing their products to the Chinese market have kept their eyes on the Clinical Trial Exemption List since it was first published. Product types added to the list are considered to be mature and proven, with a history of safety and effectiveness, according to the NMPA. Alternatively, some products are added to the list if the governing body decides that clinical trials for their product type aren’t feasible.

Clinical trials can be expensive and time-consuming, Having a product type added to the exemption list can be crucial for medical device manufacturers trying to get their products to market faster and cheaper in China.

The last draft clinical evaluation exemption list, released in July 2022, listed 11 product types under consideration for the list.

New Products Added to the NMPA Clinical Exemption List

The 47 new product types added to the NMPA clinical trial exemption list are listed below. You can use the serial numbers associated with the items to better navigate the full list, either in Chinese or English. Once this list becomes official, there will be 821 Class II product categories, 2 that could be Class II or III, and 202 Class III product categories on the Exemption List for a total of 1,025 product categories.

  1. Plasma Surgical Electrodes (Item #13)
  2. Breast Tissue Markers (Item #66)
  3. Gasket/Non-Absorbable Suture with Gasket (Item #85)
  4. Disposable Intracranial Retractor Fixation Catheter (Item #141)
  5. Hole Punch (Item #146)
  6. Transseptal Puncture System (Item #165)
  7. Osteotomy Knife (Item #190)
  8. 3d Printed Osteotomy Guide (Item #240)
  9. Urinary X-Ray Machine (Item #256)
  10. Electronic Laparoscopy (Item #324)
  11. Breath Analyzer (Item #349)
  12. Gamma Ray Detector (Item #372)
  13. Mesh Atomizer (Item #406)
  14. Intestinal Hydrotherapy Machine (Item #464)
  15. Continuous Renal Replacement Therapy Tubing (Item #479)
  16. Hemodialysis Concentrate (Item #482)
  17. Venous Blood Reservoir (Item #496)
  18. Metal Locking Plate (Item #504)
  19. Metal Locking Bone Screws (Item #505)
  20. Metal Intramedullary Nail (Item #521)
  21. Meniscus Suture System (Item #528)
  22. Craniomaxillofacial Plate System (Item #533)
  23. Sternal Ligature (Item #543)
  24. Disposable Infusion Pump (Item #579)
  25. Percutaneous Transhepatic Biliary Drainage Access Kit (Item #628)
  26. Negative Pressure Drainage Sealing Membrane (Item #636)
  27. Nasal Hemostat (Item #689)
  28. Prefilled Catheter Irrigator (Item #694)
  29. Negative Pressure Isolation Cabin For Transporting Infectious Disease Personnel (Item #714)
  30. Optometry Equipment and Appliances (Item #723)
  31. Synoptic Machine (Item #729)
  32. Pupil Distance Measuring Instrument, Pupil Distance Meter (Item #730)
  33. Ocular Aberrometer, Whole-Ocular Wavefront Aberrometer (Item #731)
  34. Corneal Pachymeter (Item #742)
  35. Tonometer (Item #743)
  36. Ophthalmic Diagnostic Aids (Item #749)
  37. Glass Cutting Head (Item #753)
  38. Disposable Intraocular Laser Fiber (Item #754)
  39. Medical Radiation Protection Glasses
  40. Medical Light Radiation Protective Glasses (Item #762)
  41. Dental Examination Light (Item #770)
  42. Root Apex Locator (Item #786)
  43. Sterile Sinus Lift Balloon (Item #800)
  44. Temporary Filling Material (Item #820)
  45. Light Curing Calcium Hydroxide Indirect Pulp Capping Agent (Item #821)
  46. Metal Materials for Dental Additive Manufacturing (Item #822)
  47. Optical Colposcopy (Item #905)

Of particular interest to medical device manufacturers and importers are the following class 3 devices:

    • Breast Tissue Markers
    • Gasket/non-absorbable suture with gasket
    • Disposable intracranial retractor fixed catheter
    • Hemodialysis Concentrate
    • Venous Blood Reservoir
    • Metal Locking Plate
    • Metal Locking Bone Screws

While some of the above products aren’t currently listed in the China Medical Device Catalogue, the NMPA may amend the Catalogue to include them soon. Additionally, if a manufacturer has registered either of these products as a class 2 device, they will need to re-register them as class 3 if they are added to the Catalogue as such.

While there weren’t any new categories added this round, software, or SaMD, are found on the exemption list, including some clinical management software, image processing and storage applications, and data processing software.

Explore the Clinical Trials Exemption List with Asia Actual’s Experts

If you have questions regarding the NMPA’s updated clinical trials exemption list, our team of experts in China can help. Contact us today for more information.

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