At EPINTEK, we are committed to providing comprehensive and integrated R&D outsourcing CRO solutions to help medical device and IVD manufacturers successfully enter the Chinese market. Our experienced regulatory affairs team works closely with our in-house laboratory experts to deliver end-to-end support for NMPA (National Medical Products Administration) registration, ensuring your product achieves compliance efficiently and gains market access faster.

What We Offer:

Technical Documentation Preparation and Optimization:
We assist in drafting, reviewing, and refining technical files to meet NMPA requirements, ensuring completeness and consistency from the start.

One-Stop Testing & Rectification Solutions:
From initial testing to performance optimization, we provide full support to ensure your product meets all necessary standards before submission.

Document Translation Services:
We offer professional translation of regulatory documents into Chinese, ensuring accuracy and compliance with NMPA expectations.

Product Classification & Innovation Channel Support:
Whether your product falls under a standard classification or qualifies for the innovation channel, we guide you through the process to expedite approval.

Registration & Certification Submission Authorized Representative:
As your official representative, we handle all aspects of the NMPA filing and registration process on your behalf, streamlining communication and submission.

Technical Communication with Review Authorities:
We act as your liaison with the NMPA and other regulatory bodies, facilitating timely and effective responses during the review process.

Quality System Consultation:
We provide guidance on establishing or improving your quality management system in line with China’s regulatory requirements.

Manufacturing License Assistance:
For domestic manufacturers, we support the application process for production licenses, ensuring alignment with NMPA regulations.

China Authorized Representative Services:
For overseas manufacturers, we serve as your local authorized agent in China, fulfilling NMPA requirements for foreign companies.

With our deep understanding of China's regulatory landscape and extensive hands-on experience, EPINTEK is your trusted partner for navigating the complexities of NMPA registration. Let us help you bring your medical products to the Chinese market with confidence, speed, and precision.

For more information about our services or to tailor specific solutions, please contact our professional team.