Service | Bradynuoen

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