Service
Our service covers from market entry service to life-cycle regulatory compliance service, and other value-added services.
- GMP Regulation Interpretation
- QMS Gap Analysis
- Supplier Audit
- Standards Identification
- Standards Gap Analysis
- Customized GMP Training
- Standards Translation
- Clinical Exemption
- Clinical Evaluation Report (CER)
- Clinical Trial
- Overseas Clinical Data
- Medical Device Annual Report (AR)
- Medical Device Recall
- Adverse Events Reporting
- Periodic Re-Evaluation of the Risks (PRER)
Need help?
Your concerns are not listed above? Send us an email or directly book an appointment to discuss.
Latest News
[China NMPA.CMDE]Review time of submissions for registration completed and transferred in March 2024
Submission type Product classification Average review time(days) Average time of...
Read MoreSummary of medical device technical review in February 2024
The following is the summary of China CMDE medical device...
Read MoreGuidelines for registration review of human papillomavirus (HPV) nucleic acid detection and genotyping reagents (2024 revised draft)
On April 23rd, China CMDE issued the draft guidance “Guidelines...
Read MoreGuidelines for Registration Review of Laparoscopic Surgery Systems Part 5: Systems and Software
On April 22nd ,2024, China CMDE has started the preparation...
Read MoreQUESTIONS?
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.