Regulatory Services

China medical device/IVD regulations are complex. China Med Device helps medtech companies by offering turn-key solutions for pre-market submission, post-market surveillance, legal representation, and Green Pathway.

CMD's China medical device regulations approval strategy workflow diagram

China medical device/In-Vitro Diagnostic (IVD) regulations are ever-changing with increasing complexity. It’s essential to have an integrated and experienced team help your organization develop the customized registration strategy needed to gain CFDA approval for any medical device/IVD to be marketed and sold in China. The China Med Device, LLC(CMD) team has an integrated and practical approach to CFDA registration and approval. Our team excels in three critical areas: technical, clinical, and regulatory.

Our China medical device/IVD regulations services have two phases: strategy development and implementation for submission and approval.

  • Develop China regulatory strategy
    1. Determine the classification of your product
    2. Assess clinical trial exemption or CER
    3. Describe local clinical indication
  • Define all aspects of china medical device/IVD regulations and standards
  • Estimate cost and timeline

China medical device/IVD regulations are ever-changing with increasing complexity. It’s essential to have an integrated and experienced team help your organization develop the customized registration strategy needed to gain CFDA approval for any medical device/IVD to be marketed and sold in China. The China Med Device, LLC(CMD) team has an integrated and practical approach to CFDA registration and approval. Our team excels in three critical areas: technical, clinical, and regulatory.

Our China medical device/IVD regulations services have two phases: strategy development and implementation for submission and approval.

  • Develop China regulatory strategy
    1. Determine the classification of your product
    2. Assess clinical trial exemption or CER
    3. Describe local clinical indication
  • Define all aspects of regulatory standards and requirements
  • Estimate cost and timeline

Pre-market Registration

[ 1 ]

Determine the classification of your product per China medical device/IVD regulations.

[ 2 ]

Access clinical trial exemption or CER.

[ 3 ]

Describe local clinical trial or indication.

Two Phase Approach

  • Strategy:
    1. Determine the China medical device/IVD regulations classification of your product
    2. Assess clinical trial exemption or CER
    3. Describe local clinical indication
    4. Documents technical standards review
  • Submission & Approval
    1. Prioritize submission deliverables
    2. Prepare, revise and translate submission dossier
    3. Local testing management and support
    4. Interact with CFDA regulatory reviewers

Downloads

Clinical Evaluation Report/Clinical Trial

If your device is in a gray area; not listed in China medical device/IVD regulations clinical trial exempt list in Class II or certain types of Class III, the manufacturer should determine the option of Clinical Evaluation Report (CER) or Clinical Trial Study (CT) and contact us.

Companies should try their best to qualify for CER instead of CT for several reasons. Most importantly, CT takes more than 12 to 18 months and cost six to sever figures, while CER typically takes 3 to 4 months and costs $20K to $50K.

The key questions for an effective CER are as follows:

  • Is there any predictive device approved by CFDA and is still valid in China?
  • Do you have sufficient technical and clinical information for the predictive device?
  • Have you done clinical trial outside China?
  • Are the clinical trial data sufficient in terms of sample size, indication, coverage, Asian/Chinese data subgroup?

For more information about CER/Clinical Trial visit our ‘Clinical Trial/Clinical Evaluation Report’ page.

MORE INFO ON CLINICAL TRIALS & CLINICAL EVALUATIONS

Green Pathway: Innovation & Priorities

Foreign (such as U.S.) medtech companies can also apply for this fast track special approval for innovative medical devices if the foreign companies meet the following requirements

a) Patent
The product should have a patent in China. You do not need to wait for the final patent approval to claim your qualification. If you have received the public notice for verification from the China patent office, you can be qualified. Furthermore, the patent does not need to be originated in China. If an entity in China is licensed with the usage or ownership rights of the patent, you can qualify. Therefore, when you apply for new patents and value China medtech market, make sure that you have China PTO coverage.

b) Innovation & Clinical Significance
The guideline spelled out what types of documents are needed to demonstrate that your medical device will meet this requirement. The product must have significant clinical application value and improvement over the current products in the categories claimed both in China and globally.

c) Prototype Product
The applicant should have completed the preliminary study of the product and have a prototyped product.

For more information about green pathway, please contact us

CONTACT US

Legal Agent Representation | Post-market Surveillance QMS

Post-Market Compliance & QMS

  • How to set up the management and data reporting for post market compliance?
  • How to Incorporate CFDA GMP into your QMS/GMP system?
  • How to be Best Prepared for your onsite inspection?

What we offer:

  • Legal representation
  • Post-market compliance (Adverse events, recall)
  • Respond to audits and other regulatory requests

Want to set up GMP/QMS system in China? Download or listen to our talk on China GMP/QMS.  The document provides comprehensive review on CFDA GMP history, latest development and standards and comparison with Western standards, onsite inspections domestically and overseas…

 

China Medical Device Regulations: CMD's Regulatory Services flow chart

For more detailed information about Post-market/QMS, please contact us.

CONTACT US

China Med Device, LLC. specializes in accelerating medical device/IVD companies commercialization in China with business-tested, turn-key solutions. Our staff are bilingual and bi-cultural with practical life science industry experience.

Frequently Asked Questions
About China Medical Device/IVD Regulations & Registration

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 CFDA national office. Domestic medical devices could be registered in the CFDA provincial office.

CMDE (Center for medical device evaluation) is the medical device registration dossier reviewing center under 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 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 CFDA will request samples for type testing. For Class I products, 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 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 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 CFDA registration process.

China Med Device Specializes in challenging Class III Implantable Device.

  • Vice President of Finance

    China Med Device (CMD) has brought a great deal of knowledge and understanding to our team to help us navigate the complexities of bringing a product to market in China. Specifically we have gained a much better understanding of the ins and outs of the China medical device market and choices of business models. CMD has walked us through the very complicated process CFDA registration guiding us not only from regulatory documentation and testing perspectives but also how the process will impact the reimbursement downstream

    Vice President of Finance
    Surgical Device
  • Vice-President, Global Regulatory/Clinical Affairs
    In my twenty years of Class Ill medical device experience, I have not had the pleasure of working with a Chinese regulatory firm as talented and knowledgeable. As CFDA is increasing their technical and clinical review, it is one of the few companies staffed to assist medical device companies in this area. Their focus and dedicated support has exceeded our expectations. In my search for a strategic partner in China, they exceeded the other companies in all areas. While they have a very experienced Regulatory and Marketing team, their technical engineering, clinical, and international project management expertise place them above other companies in this area.
    Vice-President, Global Regulatory/Clinical Affairs
    Implantable Device

Expertise with China medical device/IVD regulations & a proven track record of approved clinical results