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China Medical Device Regulation

China Medical Device Regulation

Medical Device Registration in China: Navigating NMPA Regulations

Updated on 26/01/24

Regulatory Authority: National Medical Products Administration (NMPA)

The National Medical Products Administration (NMPA) is responsible for overseeing the safety of drugs, medical devices, and cosmetics, drafting regulatory policies, and promoting new technologies. It also manages standards, regulates registration, and develops Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices.

It also manages post-market risk management, monitors adverse reactions, and handles emergency responses.

The NMPA also manages qualifications for licensed pharmacists, formulates regulations for them, and supervises their registration. It also oversees supervision and inspection of drugs, medical devices, and cosmetics, investigatesand punishes illegal activities, and participatesin international exchange and cooperation in drug regulation.

The NMPA also guides drug regulatory departments in all provinces, autonomous regions, and municipalities under the Central Government.

Link for Regulatory Authority: http://english.nmpa.gov.cn/index.html

Local Regulation:Regulations on the Supervision and Administration of Medical Devices

Classification:Class I, II, III

Listing or Registration Requirements:China requires in-country testing for all Class II and III devices, although the NMPA may accept some of the existing testing reports.

Documents Required for Registration:

  • Class I – registration dossier – no sample test reports from
  • Class II – full registration dossier and technical review
  • Class III – full registration dossier and technical review
  1. List of Documents required for Class I
  • Product Risk Analysis Document
  • Product Technical Specification
  • Product Test Report
  • Clinical Evaluation Report
  • Key Manufacturing Information (process, flowchart, material, etc.)
  • IFU and product label
  • Legal Documents
  • ISO 13485
  • Market approval at the country of origin
  • Authorization letter to the agent in China.
  • Self-declaration Letters
  1. List of Documents required for Class II and III
  • Application Form
  • Legal Documents
  • Main Safety and Efficacy Specifications List
  • Summary Data
  • Overview
    • Product description
    • Product model
    • Description of the package
    • Intended use and contraindications
    • Predicated device (if applicable).
    • Other information
  • Research Data
    • Product performance evaluation data
    • Biocompatibility evaluation data
    • Biosafety research data
    • Sterilization and disinfection process validation data
    • Shelf and package evaluation data
    • Animal research data
    • Software validation data
    • Other data if necessary
  • Manufacturing information
  • Clinical Evaluation Data
  • Product Risk Analysis Data
  • Product Technical Specifications
  • Registration Testing Report
    • Testing report issued by a CFDA certified lab
    • Preliminary evaluation comment from the testing lab
    • Artwork for the IFU and Product Label
    • Instructions for use (IFU)
  • Artwork of the product label for the minimum selling unit
  • Self-declaration Documents

Registration Timeline:

Class II & Class III Devices:

  • Chinese specification drafting: about 1 month
  • Sample testing: about 6 months
  • Clinical Evaluation Report (CER) or a local clinical study:6 months to 1.5 years
  • Filing to the CFDA: 1 month
  • CMDE review; CMDE will issue a supplementary notice: 60-90 working days.
  • Supplementary dossier preparation: maximum 1 year
  • Further CMDE review: 60 working days
  • CFDA final review and granting of the registration approval: 30 working days

Registration Fee:

  • Class II
  1. Initial Registration
  • Domestic – N/A
  • Imported – 33,761 USD
  • Variation Application
  • Domestic – N/A
  • Imported – 6,723 USD
  1. Renewal (every 5 years)
  • Domestic – N/A
  • Imported-6,531 USD
  • Class III – High Risk MD
  1. Clinical Trial Approval
  • Domestic –6,915
  • Imported – 6,915
  1. Initial Registration
  • Domestic – 24,588
  • Imported – 49,43
  1. Variation Application
  • Domestic – 8,068
  • Imported– 8,068
  1. Renewal (every 5 years)
  • Domestic – 6,531
  • Imported – 6,531

License Validity:5 Years

License Renewal: 6 Months before expiry

Special Labelling Requirements:Labelling and descriptions in Chinese

Pharmacovigilance:

Pharmacovigilance is dedicated to monitoring all adverse reactions associated with drug utilization, encompassing adverse drug reactions (ADRs), defects in product quality, medication errors, and efficacy issues. In China, the pharmacovigilance system comprehensively oversees the entire life cycle of a pharmaceutical product, from pre-approval stages to post-marketing activities. The strategic integration of pharmacovigilance planning across the entire life cycle of a product aligns with the fundamental principle outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2E guidelines.

Additional Comments:

  • To sell Class II and III medical devices in China, you usually need a Medical Device Registration Certificate from the NMPA. While in-country testing is highly encouraged, the NMPA may accept existing testing reports under certain conditions like established standards, mutual recognition agreements, or sufficient data.
  • All documents must be translated to Simplified Chinese. Consider an expert consultant for a smooth registration process.

Who should make this communication:

  • Manufacturer
  • Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process

  • Act as your Authorized representative

Why Choose Us

  • Working towards client satisfaction
  • Cost effective solutions
  • Project completion before deadline
  • Quality Regulatory affairs solutions

Contact us for free consultation: [email protected]