REGULATORY SERVICES

China Med Device helps medtech companies by offering turn-key solutions for pre-market submission, post-market surveillance, and legal representation.

China Med Device, LLC(CMD) regulatory team has the integrated practical approach to the CFDA registration and approval.  Our registration team consist three critical functional skills: technical, clinical and regulatory. With CFDA increasing complexity, it is essential for an integrated practical approach to first develop the customized strategy for your specific device.China Med Device, LLC(CMD) regulatory team has the integrated practical approach to the CFDA registration and approval. Our registration team consist three critical functional skills: technical, clinical and regulatory. With CFDA increasing complexity, it is essential for an integrated practical approach to first develop the customized strategy for your specific device.

Our regulatory 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

China Med Device, LLC(CMD) regulatory team has the integrated practical approach to the CFDA registration and approval.  Our registration team consist three critical functional skills: technical, clinical and regulatory. With CFDA increasing complexity, it is essential for an integrated practical approach to first develop the customized strategy for your specific device.China Med Device, LLC(CMD) regulatory team has the integrated practical approach to the CFDA registration and approval. Our registration team consist three critical functional skills: technical, clinical and regulatory. With CFDA increasing complexity, it is essential for an integrated practical approach to first develop the customized strategy for your specific device.

Our regulatory 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.

[ 2 ]

Access clinical trial exemption or CER.

[ 3 ]

Describe local clinical trial or indication.

Two Phase Approach

  • Strategy:
    1. Determine the 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 the gray area and not listed the clinical trial exempt list in the 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, check out our white paper or 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…

Sample slide on Medical Device QMS/GMP Key Links

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.

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

CFDA regulatory expertise & clinical results with proven track records