Service
Medical Device Registration and Approval in China, U.S., EU and Japan

From the time the company was set up, we have cultivated the desire to offer a variety of regulatory compliance and tailored solutions services to our customers in Medical Device and IVD Compliance Field.

 

Our regulatory services cover strategy, registration, agent representation, testing, clinical evaluation, CRO, QA and post market compliance:

 

  • China NMPA Medical Device Registration and Agent Service;

  • EU Medical Device Directive CE Marking, Authorized Representative Service and Free Sale Certificate Service;

  • U.S. FDA Medical Device Registration and U.S. Agent Service;

  • Japan PMDA Medical Device Registration and Agent Service.

 

What We Do for You

 

If you want to explore opportunity for your product in China, U.S., EU and Japan markets, we can assist you with the following regulatory issues:


  • Determine device classification for your medical product;

  • Represent your company with regulatory agency;

  • Develop an optimized registration route to approval in China, U.S., EU and Japan;

  • Investigate all relevant compulsory national & industrial standards applicable to your products;

  • Prepare and manage documents for registration application or filing the product technical requirements;

  • Coordinate registration testing in lab authorized by authorities and communicate throughout the testing process;

  • Coordinate clinical study in China if device do not exempt clinical study;

  • Assist your medical device company with quality control (QC) and quality assurance (QA) systems and compliance;

  • Translate documents in Chinese/English/Japanese;

  • Offer guidance on dossier preparation for final submission;

  • Submit application and track status in the subsequent procedures;

  • Answer telephone calls from reviewers; maintain communication with the chief reviewer, expedite their understanding of the product, clear their questions and concerns; handle additional information requests;

  • Perform obligations as representative agent and after sales service agent: collect information, contact with authorities and provide relevant reports in case of post-market recalls, adverse events and other quality issues;

  • Obtain the Free Sales Certificate (FSC) / Certificate of Marketability;

  • Medical device registration renewals.


For more details regarding the regulatory requirements and registration process, contract usMedright tech Inc. can assist you with high-standard of services at competitive prices. 


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