Medical Devices

Medical Devices

NMPA (National Medical Product Administration)

China’s State Food and Drug Administration (CFDA China, 国家药品监督管理局, renamed to National Medical Products Administration or NMPA China in 2018) is Chinese government’s administrative body responsible for regulating pharmaceuticals, medical devices, and cosmetics in China.

According to degree of risk (from low to high), the classifications of medical devices are divided into class I, class II and class III in due order.

The risk degree of a medical device shall be determined comprehensively according to the intended purpose, structural characteristics, pattern of use, status of use as well as whether the device is body contacting.

  • 01   Active Surgical Devices
  • 02   Passive Surgical Devices
  • 03   Neurological and Cardiovascular Surgical Devices
  • 04   Orthopedic Surgical Devices
  • 05   Radiotherapy Devices
  • 06   Medical Imaging Devices
  • 07   Medical Diagnostic and Monitoring Devices
  • 08   Respiratory, Anesthetic and First-aid Devices
  • 09   Physiotherapy Devices
  • 10   Blood Transfusion, Dialysis and Extracorporeal Circulation Instruments
  • 11   Disinfection and Sterilization Devices of Medical Devices
  • 12   Active Implantable Devices
  • 13   Passive Implantable Devices
  • 14   Injection, Nursing and Protection Devices
  • 15   Patient Bearing Devices
  • 16   Ophthalmic Devices
  • 17   Stomatological Devices
  • 18   Gynaecological and Obstetrical, Assisted Reproduction and Contraceptive Devices
  • 19   Medical Rehabilitation Devices
  • 20   Equipment Used in TCM
  • 21   Medical Softwares
  • 22   Clinical Examination Instruments

You have dough if your product is under CFDA certification please contact us.

Medical Equipments 

National Medical Product Administration in China:

Body Contacting Devices Risks Assessment / Class
Body Contacting Devices

Notes: 1. “I”,“II”and“III”herein respectively refer to class I, II and III medical devices.  

            2. “-”herein means the situation is inapplicable to any class of medical devices. 

Medical device and IVD registration in China:

Medical devices are regulated by the National Medical Product Administration (NMPA), Manufacturers must register their devices with the NMPA before selling or distributing in China.

 

 

The NMPA reviews all device applications, and has strict requirements for submission documentation, testing, and clinical data.

Product Catalog Exemption:

According to an NMPA, the regulator has added 84 medical device product types as well as 277 IVD product types to its summary clinical exemption list. With these latest additions, NMPA has now exempted 855 medical device types and 393 IVD types from clinical trial requirements in China.

The draft Catalog added exemptions for 142 medical devices, including 40 Class III:

  • Venous intrahepatic puncture

  • Infusion catheter

  • Contrast balloon catheter

  • Disposable hemodialysis tubing

  • Radiation protection glasses

  • Dental medullary material

  • Metal materials for 3D-ptinting dental device

  • In vitro assisted reproductive fluid

  • ……

It added exemptions for 42 IVDs, including 14 Class III:

  • Cocaine detection reagent

  • Morphine detection reagent

  • Tetrahydrocannabinol acid detection test

  • Amphetamine detection reagent

  • ……

CCIC STLQ can take care of all CCC and Voluntary certification procedures by representing you directly as Agent for China authorities and competent body for inspection, testing and certification,

Contact Us:

Info@ccic-stlq.com