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China Medical Device Regulations

Agency
The National Medical Products Administration (NMPA) regulates medical devices in China.
Medical Device Definition
A medical device in China means any instrument, apparatus, appliance, material, or another article, whether used alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by utilizing pharmacology, immunology, or metabolism. Still, it may be assisted in its function by such means, the use of which is to achieve the following intended objectives:
  • Diagnosis, prevention, monitoring, treatment, or relief of diseases;
  • Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap condition;
  • Investigation, replacement, or modification for anatomy or a physiological process;
  • Control of conception.
Medical Device Classification System
International Classification Risk Level Examples
Class I Low risk Bandages, examination gloves, and surgical gowns.
Class II Medium risk Diagnostic reagents, powered wheelchairs, and artificial joints.
Class III High Risk Implantable pacemakers, artificial heart valves, and certain diagnostic imaging equipment.
Approval Process
Classification Approval procedure
Class I Class I medical devices shall be inspected, approved and granted with a registration certificate by the drug regulatory authority of the government of the municipalities consisting of districts.
Class II Class II medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government.
Class III Class III medical devices shall be inspected, approved and granted with registration certificates by the drug regulatory authority directly under the State Council..
Additional Information
Approval timeline 1 month to 18 months (Depends on Class of medical device)
License validity period 5 years
Fees Class II :- $30623 Class III :- $44839
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