Registration Filing Service
Expert team assisting with the full medical device registration and filing process
1. Product Classification
Determine the management class (Class I/II/III) based on product characteristics and choose the correct registration path
2. Product Technical Requirements
Prepare product technical requirement documents in compliance with regulatory requirements
3. Registration Testing
Coordinate qualified testing institutions to complete product registration testing
4. Clinical Evaluation
Assess whether clinical trials are required based on product risk level and prepare the clinical evaluation report
5. Registration Filing
Compile the full application dossier and submit it to the provincial or national NMPA
6. Review Follow-up
Track the review progress and supplement materials promptly until the registration certificate is obtained
Cooperation Models
Class II Medical Devices
110+ Class II medical device registrations covering medical dressings, aesthetic repair and more
Class 100,000 sterile cleanroom compliant with medical device GMP
Professional registration team assisting clients with product registration and filing
Full-process quality traceability with retention samples tested for every batch
Class III Medical Devices
Class III medical device R&D including implantable and interventional high-risk products
Class 10,000 cleanroom meeting Class III medical device production environment requirements
Professional registration team assisting clients with product registration and filing
Clinical evaluations with top-tier (Grade IIIA) hospitals ensure product safety and efficacy
⚠️ Important: Class III Medical Device registration has a long approval cycle (typically 18-36 months), requiring NMPA technical review. Plan ahead. Weitai Group holds 110+ Class II Medical Device registrations and extensive Class III registration experience, providing full-process registration support.
Our Advantages
Deep expertise in aesthetic efficacy skincare, serving 1,000+ brand clients
Proven formulas across all categories, supporting rapid custom development
150,000㎡ production area across multiple bases ensures capacity
110+ device registrations and full international certifications — compliant and verifiable