Mission
To streamline medical device compliance with expert guidance, practical support, and end-to-end solutions for China and international market access.
Connection.
Management.
Solution.
Your Connection Management Solution for Medtech Regulatory Compliance.
Regulatory support for China market entry and international access across medical devices and IVDs.
Talk to our team
Cleared. Mastered. Secured.
What we bring
One-window coordination
Global route planning
12+ years experience
50+ projects supported
Quality-system readiness
Practical planning
Our services
Clear support for every stage of market access.
Four connected service areas for medical device and IVD market access, from route planning to continued compliance.
Explore all servicesFurther detail
We manage the registration route from product assessment and technical documentation through submission planning and regulatory follow-up for China and international market access.
Our purpose
A clear direction for every market access project.
Our mission and vision guide practical, responsible regulatory support for manufacturers entering China and international markets.
Vision
To be the trusted partner for navigating complex regulations and accelerating compliant market entry worldwide.
Our experience in numbers
Measured experience. Clear focus.
A concise view of the experience and service focus behind CMS Medtech's regulatory work.
12+
Years of core member experience
50+
International access projects supported
100+
Global clients
Our Process
One route, from first assessment to continued readiness.
A practical route from first assessment to continued regulatory readiness.
- 1
Assess
Clarify the product, intended use, classification, and target-market requirements.
- 2
Prepare
Build a practical evidence, documentation, quality, and representation plan.
- 3
Document
Coordinate controlled technical files, quality records, and submission materials.
- 4
Register
Support submission planning, correspondence, and regulatory follow-up.
- 5
Implement
Translate applicable requirements into workable quality and regulatory actions.
- 6
Maintain
Support changes, surveillance, training, and continued regulatory readiness.
Assess
Clarify the product, intended use, classification, and target-market requirements.
1
2
Prepare
Build a practical evidence, documentation, quality, and representation plan.
Document
Coordinate controlled technical files, quality records, and submission materials.
3
4
Register
Support submission planning, correspondence, and regulatory follow-up.
Implement
Translate applicable requirements into workable quality and regulatory actions.
5
6
Maintain
Support changes, surveillance, training, and continued regulatory readiness.
Regulatory intelligence
News & Regulatory Sources
Bi-monthly regulatory news and practical interpretations for medical devices and IVDs in major markets.
China Market Access
NMPA-facing registration, IVD evidence, and controlled documentation considerations.
EU MDR & IVDR Watch
Updates and practical planning notes for European medical device and IVD obligations.
FDA & Quality Systems
U.S. regulatory and quality-system developments relevant to device manufacturers.
Global Market Briefs
Focused regulatory watch items for IVDs and medical devices across major markets.
Talk to CMS Medtech
Plan your market access route.
For market access, registration support, ISO and GMP preparation, or regulatory training, contact our team directly or scan the QR code.
info@cmsscidoc.cn
R2304, Bld.7, Shunlian Mach-zone, Xingye Road No.4, Guanglong Industrial Park, Chencun, Foshan, GD, 528313, CN