Homepage > Service
Service

Before your registration

You should know

  • Your product category
  • Clinical trial is required or not
  • If your clinical trial data in EU can be used or not
  • CER is required or not
  • If your EU CER can be used or not
  • Any other clinical pathways to avoid clinical trial
  • Local type testing is required or not
  • Your estimated registration timeline
  • Your estimated budget
  • If you need establish an entity in China
  • If you have a chance to consult NMPA before registration

During your registration

You should know

  • Your registration dossiers are complete or not
  • How is China requirement on shelf life
  • How to write software description documents/cybersecurity document
  • How is China requirement on disinfection/steralization
  • How to address type testing problems
  • Your biocompatability report can be used or not
  • How to write China CER
  • How to select hospital site/KOL for clinical trial
  • How is the process of clinical trial as per China GCP
  • How to solve questions from NMPA reviewers during supplementary phase

After your registration

You should know

  • Certificate modification is required or not in any changes of your product
  • When to renew your registration certificate
  • If you need additional type testing during renewal
  • If your labeling is compliant to China requirement
  • If you need to update your IFU
  • How to handle AE and recall
  • How to handle the overseas NMPA onsite inspection
  • How to find and qualify distributors

About BradyKnows

BradyKnows, headquartered in Silicon Valley in the United States, is an international leading consulting company delivering integrated lifecycle services for Medical Devices and In Vitro Diagnostic Products.
  BradyKnows strives to provide effective solutions for medical and biotechnology companies with product design and development, manufacturing, clinical research, regulatory registration, commercialization, and post-market management.
  BradyKnows endeavors to introduce innovative products to emerging markets and provide more patients and countries with high-quality health care.
  Mission
Together with our clients, introduce innovative and life-improving medical and biotechnology products to patients worldwide.

BradyKnows Inc.
Headquarter: San Jose, USA
China Offices: Beijing, Shanghai, Hainan