Our Mission
To streamline medical device compliance with expert guidance, practical support, and end-to-end solutions for China and international market access.
Focus on compliance rigor and commercial entry
Medical Device & IVD Regulatory Consulting
Connection.
Management.
Solution.
Your Connection Management Solution for Medtech Regulatory Compliance.
Regulatory support for China NMPA registration and international market access across medical devices and IVDs.
Cleared. Mastered. Secured.
What we bring
Regulatory capability across global jurisdictions
Our services
Clear regulatory support for every stage of market access.
Four connected service areas for medical device and IVD market access, from regulatory pathway planning to continued compliance.
Select a service to preview its scope below
Service scope preview
Medical Device & IVD Registration
We coordinate the regulatory route from intended-use and classification assessment through technical documentation, evidence planning, submission and authority-review support for China and international markets.
Regulatory pathways
One coordinated route to multiple markets.
Use a regional framework to plan efficiently, then adapt the regulatory strategy to each jurisdiction, product classification and intended use.
Target regulatory regions
A consistent planning method
From route assessment to continued compliance.
Medical device and IVD market entry requires early strategic alignment, robust clinical and technical evidence, and continuous compliance maintenance.
- 01 Assess
- 02 Plan
- 03 Prepare
- 04 Submit
- 05 Maintain
The final pathway depends on the device or IVD, classification, evidence base, manufacturing structure, responsible entities and current requirements in the target market.
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.
Our Vision
To be the trusted partner for navigating complex regulations and accelerating compliant market entry worldwide.
Serving as a long-term strategic regulatory ally
Our experience in numbers
Measured experience. Clear regulatory focus.
A concise view of the experience and service focus behind CMS Medtech's medical device regulatory work.
12+
Years of core team regulatory experience
Dedicated to regulatory clearance
Proven regulatory track record
50+
International market access projects supported
Across major global jurisdictions
Proven regulatory track record
100+
Global medtech clients
Spanning medical devices & IVDs
Proven regulatory track record
Our process
One route, from initial assessment to continued compliance.
A practical, traceable route from initial regulatory assessment to continued compliance readiness.
01
Assess
Clarify the product, intended use, classification and target-market requirements.
Phase 01
02
Plan
Define the evidence, technical documentation, QMS and responsible-entity strategy.
Phase 02
03
Document
Coordinate controlled technical documentation, quality records and submission materials.
Phase 03
04
Submit
Support regulatory submission, authority correspondence and review-question responses.
Phase 04
05
Implement
Translate applicable requirements into workable quality and regulatory controls.
Phase 05
06
Maintain
Support changes, post-market surveillance, vigilance, training and continued compliance.
Phase 06
Regulatory intelligence
Medical Device & IVD Regulatory News
Regulatory updates and practical interpretations for medical devices and IVDs in major markets, updated regularly.
China China Market Access
NMPA registration, IVD evidence and controlled technical documentation considerations.
Read related updates
Europe EU MDR & IVDR Watch
Regulatory updates and practical planning for European medical device and IVD obligations.
Read related updates
United States FDA & Quality Management Systems
U.S. registration and quality management system developments relevant to device manufacturers.
Read related updates
IVD Global Regulatory Briefs
Focused regulatory updates for medical devices and IVDs across major markets.
Read related updates
Talk to CMS Medtech
Plan your medical device market access route.
For medical device or IVD registration, ISO 13485 QMS, authorized representative, post-market or regulatory training support, contact our team directly or scan the QR code.
Official Email
info@cmsscidoc.cnR2304, Bld.7, Shunlian Mach-zone, Xingye Road No.4, Guanglong Industrial Park, Chencun, Foshan, GD, 528313, CN