Before entry
Define the route
Classification, evidence and the target market determine the required pre-submission work.
Services
Professional regulatory support from pathway planning to market entry.
CMS provides one coordination point for complex medical device and IVD market access: registration strategy, responsible-entity support, ISO 13485 QMS readiness and post-market compliance for China and international markets.
Why these services matter
Market access is a sequence of connected regulatory obligations.
During entry
Keep responsibilities clear
Define the responsible entity, manufacturer and supply-chain obligations required by the jurisdiction.
After entry
Maintain compliance
Post-market surveillance, vigilance, change control and quality activities maintain compliance.
Service detail
Four connected service areas, coordinated through one team.
Each service can address a specific need or combine into one coordinated market access and life-cycle compliance route.
01 Medical Device & IVD RegistrationDefine a defensible route before committing time and resources.
Market access begins with a defensible regulatory pathway. We assess the product, intended use, classification and evidence expectations, then coordinate technical documentation, submission and authority-review work for a clear registration plan.
- Product classification and pathway assessment
- Technical documentation and dossier readiness
- Submission and authority-review support
- Registration strategy for China and international markets
02 In-Country Authorized Representative ServicesEstablish and maintain the responsible regulatory contact required by the target jurisdiction.
Many medical device frameworks require a responsible in-country entity when the manufacturer is established elsewhere. CMS supports the appropriate authorized representative or responsible-entity structure, regulatory communication, registration maintenance, vigilance coordination and ongoing manufacturer obligations.
- Authorized representative or responsible-entity support
- Regulatory correspondence
- Registration and certificate maintenance
- Vigilance and ongoing manufacturer obligations
03 Regulatory Affairs, QMS Consulting & TrainingTranslate evolving regulatory requirements into practical operating systems.
Durable market access depends on the regulatory and quality system behind the registration. We turn complex requirements into focused actions through regulatory strategy, ISO 13485 QMS consulting, applicable GMP readiness, audit preparation, outsourced support and role-specific training.
- Regulatory and quality strategy and gap assessment
- ISO 13485 and applicable GMP readiness
- Outsourced regulatory and quality support
- Regulatory, quality and compliance training
04 Post-Market Surveillance & VigilanceMaintain product safety and regulatory compliance after market entry.
Regulatory obligations continue after approval. We help establish post-market surveillance, complaint trending, vigilance and incident reporting, field safety corrective action, recall readiness and regulatory change-assessment processes.
- Post-market surveillance systems and plans
- Incident and vigilance reporting support
- Complaint trending, FSCA and recall readiness
- Regulatory change and life-cycle compliance review
How we work
One route, from initial assessment to continued compliance.
Assess
Clarify the product, intended use, classification and target-market requirements.
Plan
Define the evidence, technical documentation, QMS and responsible-entity strategy.
Submit
Coordinate submission, authority correspondence and review follow-up.
Maintain
Support post-market surveillance, changes, training and continued compliance.
Start with the product and target market. We turn regulatory questions into clear, actionable next steps.
Contact CMS Medtech