Medical Device Registration Declaration

Relying on a professional technical service team and high-quality strategic cooperation resources, we provide registration consulting services for domestic and foreign medical device companies, and assist companies in the preparation of product technical documents, product testing, clinical evaluation and clinical trials, declaration and tracking, related qualifications, etc. The link is started, and a bridge is established to escort the smooth launch of the product.

Introduction of domestic registered agency business

· Provide 44 services ·Can be freely matched 

· Professional RA team docking 

· Project management mode 

· Provide third-party professional testing institutions 

· Provide professional registration templates and related training

Introduction of International Registration Agency Business

Medical Device Registration Declaration1

Registered Agent Service

Provide dedicated registration agent services for enterprises that urgently need to enter the market but have not selected a suitable medical device registration agent. The service shall be replaced by the agent selected by the enterprise within the specified time.

Agent service is a convenient service for enterprises intending to enter the market. Think for the enterprise and help the enterprise improve the conditions for entering the market. When appropriate, the rights and responsibilities of the agent shall be negotiated and transferred back to the enterprise.

Registration document writing and guidance

Provide separate document writing services for companies in the medical device registration stage. This service is written by the Global Regulatory Affairs (RA) team in accordance with the laws and regulations promulgated by relevant regulatory agencies, as well as the real product information provided by the enterprise.

Medical Device Registration Declaration2

Registration Guidance Business Introduction

Medical Device Registration Declaration3