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
Announcement on the arrangements for Pre-Submission Communication from November to December 2024 (No. 28, 2024)
CMDE has announced the following schedule for Pre-Submission Communication: Date...
Read MoreInformation related to medical device registration licenses in China（As of August 31）
As of August 31st, the medical device licensing and filing...
Read MoreMedical Device Administration Law of the People’s Republic of China (Draft)
On August 28, 2024, China NMPA issued the Medical Device...
Read MoreAnnouncement on the arrangements for Pre-Submission Communication from September to October 2024 (No. 25, 2024)
CMDE has announced the following schedule for Pre-Submission Communication: Date...
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.