Product Registration

Product registration is scientifical and artistical process. Extensive industry knowledge, deep regulatory experience, and understanding of the relative CDME reviewers’ styles have great impact on the registration process and result. Good project management practice and good communication skills with both clients and NMPA also play an important role throughout the registration process. We provide you the professional service by taking care of each of the above aspects, no matter it is the initial registration, the product license renewal, the supplemental submission, or the modification submission.

Product Registration

Listen To You

You are the king. Let us know your products.

Identify The GB/YY Standards

China has so many innovative programs. Our US team will collaborate with China team to match your case to the best pathway for you.

Product Technical Requirement (PTR)

We will communicate with you and review your documents to confirm its feasibility.

Type Testing

A comprehensive and organized report will be submitted to you in a timely manner.

Preclinical Safety Testing

You are the king. Let us know your products.

CER Or Clinical Trial

China has so many innovative programs. Our US team will collaborate with China team to match your case to the best pathway for you.

Dossier Preparation And Submission

We will communicate with you and review your documents to confirm its feasibility.

Approval

A comprehensive and organized report will be submitted to you in a timely manner.

QUESTIONS?

Whether you’re curious about a free talk, or even press, we’re here to answer any questions.

GVM MedTech RA/QA Service

Why Choose US

Good Knowledge

We dedicate to study the regulation update context that we provide you the accurate insight of the regulations.

Bilingual & Cross-Cultural Experts

Our project manager (PM), business development rep (BD), and part of the experts have background working in US and China.

A network of industry experts

The diversity of the medical device industry makes expert networks extremely important

Hard Working

We respect your time and money, our U.S. and Chinese teams worked together to create a 7/24 rhythm. We will try our best to keep your project proceed in a timely manner.