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 NMPA registration and international market access across medical devices and IVDs.
What we bring
One-window coordination
Global route planning
12+ years experience
50+ projects supported
Quality management system readiness
Practical planning
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 preview
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.
Read the full service scopeRegulatory 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.
01
China Market
02Europe
03North America
04Latin America
05Asia-Pacific & Oceania
06Middle East & Africa
07Eurasia
A consistent planning method
From route assessment to continued compliance.
- 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.
View full regional pathwaysOur 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 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
50+
International market access projects supported
100+
Global clients
Our process
One route, from initial assessment to continued compliance.
A practical, traceable route from initial regulatory assessment to continued compliance readiness.
- 1
Assess
Clarify the product, intended use, classification and target-market requirements.
- 2
Plan
Define the evidence, technical documentation, QMS and responsible-entity strategy.
- 3
Document
Coordinate controlled technical documentation, quality records and submission materials.
- 4
Submit
Support regulatory submission, authority correspondence and review-question responses.
- 5
Implement
Translate applicable requirements into workable quality and regulatory controls.
- 6
Maintain
Support changes, post-market surveillance, vigilance, training and continued compliance.
Assess
Clarify the product, intended use, classification and target-market requirements.
1
2
Plan
Define the evidence, technical documentation, QMS and responsible-entity strategy.
Document
Coordinate controlled technical documentation, quality records and submission materials.
3
4
Submit
Support regulatory submission, authority correspondence and review-question responses.
Implement
Translate applicable requirements into workable quality and regulatory controls.
5
6
Maintain
Support changes, post-market surveillance, vigilance, training and continued compliance.
Regulatory intelligence
Medical Device & IVD Regulatory News
Regulatory updates and practical interpretations for medical devices and IVDs in major markets, updated regularly.
China Market Access
NMPA registration, IVD evidence and controlled technical documentation considerations.
Read related updates
EU MDR & IVDR Watch
Regulatory updates and practical planning for European medical device and IVD obligations.
Read related updates
FDA & Quality Management Systems
U.S. registration and quality management system developments relevant to device manufacturers.
Read related updates
Global Regulatory Briefs
Focused regulatory updates for medical devices and IVDs across major markets.
Read related updatesTalk 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.
info@cmsscidoc.cn
R2304, Bld.7, Shunlian Mach-zone, Xingye Road No.4, Guanglong Industrial Park, Chencun, Foshan, GD, 528313, CN