Regulatory Services KARL

200+ Medtech Companies Entered China With Us

China Med Device is the go-to team for your China initiative. Strategically located in Boston and Beijing, our team executes a turn-key solution covering your complete product life cycle:

  • Regulatory strategy
  • Registration & renewal submission
  • PTR & local type testing
  • CER/CRO/overseas clinical data/RWD
  • Quality management system (QMS)
  • Post-market surveillance (PMS)
  • In-country regulatory representation
  • IVD/CDx Expertise

RA Strategy and Consulting

China medical device/In-Vitro Diagnostic (IVD) regulations are ever-changing with increasing complexity. Our integrated and seasoned team can help you develop a customized RA strategy and deal with complex regulatory challenges. Our team excels in three critical areas: technical, clinical, and regulatory. READ MORE…

Registration Renewal & Modification

China NMPA has its own specific and special requirements for product registration, renewal and modification. China Med Device’s team have years of hands-on experience for China registration and have got 1000+ certificates approved. We review and prepare the registration dossier, provide on-site type testing support, communicate closely with NMPA to accelerate our clients to get their product to enter China market. READ MORE…

Quality Management System (QMS), Post Market Surveillance

The Chinese government is enhancing efforts in post-market surveillance by investing heavily in both financial resources as well as implementing more comprehensive and stricter regulations. China Med Device QA team can help our clients to establish a compliant Quality Management System, provide incident solutions for adverse events, recalls, and overseas inspection. READ MORE…

In-country Representation

China Med Device can be your In-country Representation (legal agent) in China, which means you don’t need to set up an office in China. Our bilingual and bi-culture team will fulfill your local agent requirements from pre- thru post-market. READ MORE…

IVD/CDx Expertise

To be added. READ MORE…

China Regulatory Services FAQ

NMPA (CFDA), formerly SFDA (State Food and Drug Administration) is the arm of the Chinese government that sets China medical device/IVD regulations. All medical devices/IVD’s imported into China must be registered in the NMPA (CFDA) national office. Domestic medical devices could be registered in the NMPA (CFDA) provincial office.

CMDE (Center for medical device evaluation) is the medical device registration dossier reviewing center under NMPA (CFDA). There are 6 departments in CMDE. Each one is responsible for reviewing registrations of different categories of medical devices//IVD’s.

Medical Device

  • Class I: The safety and effectiveness of Class I medical device/IVD can be ensured by normal administration.
  • Class II: The safety and effectiveness of Class II medical device/IVD should be controlled.
  • Class III: Human implants; life support and substance; have potential risk to human body; the safety and effectiveness needs to be controlled strictly.

IVD

  • Class III: 1) Reagents related to the testing of pathogenic pathogen antigens, antibodies and nucleic acids; 2) Reagents related to blood type and tissue type; 3) Reagents related to human genetic testing; 4) Reagents related to hereditary diseases; 5) Reagents related to narcotic drugs, psychotropic substances and medical toxic drug testing; 6) Reagents related to the therapeutic targets detection; 7) Reagents related to tumor marker detection; 8) Reagents related to allergies (allergens)
  • Class II: Except for the reagents that are classified as Class I and Class III, all the other reagents are Class II.
  • Class I: 1) Microbiological medium (not used for microbiological identification and susceptibility testing); 2) Sample processing products, such as hemolytic agents, diluents and dyeing solution.

Class I Filing:

  1. Class I medical device/IVD filing form
  2. Safety risk analysis report
  3. Technical standard
  4. Product testing report
  5. Clinical evaluation materials
  6. IFU and minimum selling unit label design sample
  7. Production information
  8. Legal documents
  9. Self-declaration

Class II & III Registration

  1. Application Form
  2. Legal documents
  3. Medical device/IVD safety and effectiveness basic requirements list
  4. Summary
    • Overview
    • Product description
    • Model and specification
    • Packaging
    • Clinical indication and contraindications
    • Referred predicate product
    • Others
  5. Research Materials
    • Product performance research
    • Biocompatibility evaluation research
    • Bio-safety research
    • Sterilization and disinfection process research
    • Shelf validity period and package evaluation data
    • Animal research
    • Software research
    • Other
  6. Manufacturing Information
    • Production process of active/inactive device
    • Production site
  7. Clinical Evaluation Materials
  8. Product Risk Analysis Materials
  9. Product Technical Standard
  10. Product Registration Testing Report
  11. IFU and Label Sample
  12. Self-declaration Documents

In almost all situations for Class II and Class III devices, the NMPA (CFDA) will request samples for type testing. The testing centers will use the product standard to determine what tests to conduct.

  • For Class II and Class III devices, the NMPA (CFDA) will request samples for type testing. For Class I products, NMPA (CFDA) will accept a company’s foreign testing data.
  • Testing centers will test all specification items listed in the Product Technical Specifications (YZB Product Standard which is drafted by the company).
  • For each specification item, testing centers will utilize the testing method described in the Product Technical Specifications.
  • While conducting the tests, the NMPA (CFDA) requests that testing centers provide comments on the company’s drafted Product Technical Specifications.
  • The comments from the testing center should be submitted together with the testing report to avoid repeats and additional testing, which occurs frequently, leading to long delays in the registration process.

The testing report will be issued by a NMPA (CFDA) certified national testing center, which can be freely selected from the CFDA list. It is only valid for 1 year, and once it expires, a company must start again to obtain a new valid testing report.

Clinical trials must be conducted for all Class II & III medical device/IVD registrations except in the following situations:

  • The product has a clear working mechanism, finalized design, and mature production technology. A medical device/IVD of the same variety is already on the market and has been used in clinical practice for many years without any record of serious adverse events. There will also not be any changes to the product’s conventional usage.
  • The safety and efficacy of the product can be proven through non-clinical evaluations.
  • The safety and efficacy of the product can be proven through the analysis and evaluation of data obtained from clinical trials or clinical application of other medical devices of the same variety.

Yes. You need approval from either the country of origin or the country where the applicant is located to start the NMPA (CFDA) registration process.