India CDSCO Medical Device Registration Services
Enter the Indian medical device market with confidence. Cisema helps medical device and in vitro diagnostic (IVD) manufacturers navigate India’s Medical Devices Rules, 2017 (MDR 2017), from regulatory strategy and technical documentation to import licensing and post-market compliance.
Our regulatory expertise helps you identify the right approval pathway, prepare the required documentation, and manage regulatory obligations throughout your product’s lifecycle.
India Medical Device Registration Services
Cisema supports medical device and IVD manufacturers with regulatory planning, application preparation, and import licensing under the Central Drugs Standard Control Organisation (CDSCO).
Regulatory Strategy & Risk Classification
Technical Documentation & Dossier Preparation
Import License Application & Submission
Post-Approval Services
Optional Services
Authorized Agent & Import Licensing Support in India
Foreign medical device manufacturers generally need an eligible Indian authorized agent to obtain an import license where required. Cisema helps manufacturers navigate the applicable requirements, coordinate documentation, and manage the regulatory steps involved in establishing Indian market access.
Authorized Agent & Licensing Coordination
Importer & Distributor Documentation
Regulatory Compliance
Post-Market Vigilance
Quality Management & Inspection Coordination
Regulatory Strategy
Global Communication
Medical Device Post-Market Surveillance & Safety Services in India
Maintain oversight of product safety after market entry. Cisema supports medical device manufacturers with adverse event assessment, regulatory reporting, corrective actions, and ongoing post-market compliance in India, including applicable requirements under the Materiovigilance Programme of India (MvPI).
Post-Market Safety & Incident Monitoring
Adverse Event Reporting & Regulatory Notifications
FSCA & Recall Support
Post-Market Compliance Support
Quality Control Inspection Services for Medical Devices in India
Protect product quality and reduce supply-chain risk with Cisema’s inspection services for medical devices and IVDs in India. From incoming goods to final product release, we assess products against agreed specifications and applicable quality requirements.
Incoming Goods Inspections
In-Process Quality Monitoring
Final Product Release Inspections
Special Inspection Projects
Transparent Reporting
Why Work with Cisema?
One Partner, Full Lifecycle Support
From pre-market strategy to post-market compliance, we provide support to internal regulatory teams and ensure seamless lifecycle management.
Regional Reach, Global Presence
Based in Asia and Europe with a global team delivering global reach.
Cross-Industry Expertise
Pharma, biotech, medical devices, cosmetics, supplements, veterinary, industrial and consumer goods.
Proven Results
Over 20 years of regulatory submissions, regulatory expertise, and approvals to drive business success.
India CDSCO Medical Device Registration FAQs
Cisema supports foreign medical device and in vitrodiagnostic (IVD) manufacturers throughout the CDSCO registration process, fromregulatory strategy and device classification to technical documentation,import license applications, endorsement applications, and post-approval compliance.
Requirements depend on the device’s risk classification, intended use, and applicable regulatory pathway. Cisema helps manufacturers determine device classifications and applicable requirements, prepare technical documentation, assess clinical evaluation and performance evaluation requirements, and coordinate import license applications under India’s Medical Devices Rules, 2017.
Foreign manufacturers generally need an eligible Indian authorized agent to apply for an import license where required. Cisema helps manufacturers navigate authorized agent requirements, coordinate documentation, and manage regulatory submissions.
Registration costs and timelines depend on the device’s risk class, documentation readiness, and regulatory review requirements. Cisema assesses product-specific requirements, identifies documentation gaps, and helps manufacturers plan their regulatory budgets and India market entry.
Yes. Cisema supports ongoing regulatory compliance, including post-approval changes to products and manufacturing sites, license amendments, post-market surveillance, adverse event reporting, recall coordination, and quality inspection services, helping manufacturers manage their obligations throughout the product lifecycle.