Agency Registration Service for Medical Devices of Domestic and Foreign Origin

Agency Registration Services for Medical Devices of domestic and Foreign Origins

Registration agency for medical devices of domestic and foreign origins refers to the whole package of registration services we provide as our golden services. The service package includes: Preparation of registration documentation, formulation of product standards, filing of standards, product submissions for tests, product submissions for approval, acquisition of registration certificates, etc.

Based on our rich professional background, familiarity with policies and regulations governing medical devices, organizational structure and working procedures of administrative agencies and accumulation of field experiences and case studies, we know how to provide solutions to knotty problems. Many world-renowned medical device companies engage our consultancy service on Chinese laws and regulations and agency service on product registration for market access.

In addition, our company has formed consultancy guidance guidelines. Being practical and case-specific, these guidelines enable enterprises to grasp the outlines of regulations on medical devices and raise working efficiency.


Formulation of Registration Standards for Medial Devices of Domestic and Foreign Origins

Formulation of registration standards for medical devices of domestic and foreign origins is an agency service based on separate items of registration materials. Product standards for medical device registration are a major difficulty in preparing for registration. Moderate requirements should be raised under the precondition of a sound knowledge of technical regulations and the product to be registered. As a result, many companies contract out this difficult job to reduce costs. 

Our staff can ensure the quality of the standards written.


Consultation on Regulations Governing Sales and Production Licensing of Medical Devices

Regulation and approval of sales and production licenses of medical devices is an important part of medical device regulation. After on-site inspections, medical device regulatory agencies at provincial and city levels may issue sales licenses or production licenses for medical devices. Our company will counsel clients on documentation and preparations for inspections to acquire licenses.

Consultation on Other Questions Related to the Regulation of Medical Devices

Because of the great variety of medical devices and the complexity of environment and conditions, many problems arising from the regulation of medical devices can not be solved through consulting current laws and regulations. We can be a help.