Expert Medical Device Consulting
Navigating CDSCO for compliance and success.
Key regulatory framework
Overview of the licence/registration process under the Central Drugs Standard Control Organisation (CDSCO) / Medical Devices Rules, 2017 (MDR-2017) in India
- Import licence for medical devices: Application in Form MD-14 (to import) → Licence in Form MD-15.
- Manufacturing licence for “manufacture for sale or distribution” of medical devices: For Class C & D, apply via Form MD-7/MD-8 (for sale/distribution) → licence forms MD-9/MD-10.
- Test licence (for manufacture or import for test, evaluation, clinical investigation, demonstration, training) – Forms MD-12/MD-13 (manufacture), MD-16/MD-17 (import) respectively.
- Registration certificate (especially for low-risk devices) – earlier there was a “registration” (rather than full licence) regime for some devices. For example, Class A (non-sterile & non-measuring) devices had to register instead of full licence.
OUR SERVICES
CDSCO Medical Device Registration
CDSCO Medical Device Registration
CDSCO Medical Device Registration
End-to-end support for registration and licensing of medical devices in India under MDR-2017.
Import License Assistance
CDSCO Medical Device Registration
CDSCO Medical Device Registration
Preparation and submission of applications for CDSCO import licenses for medical devices and IVDs.
Manufacturing License Support
CDSCO Medical Device Registration
Regulatory Strategy & Product Classification
Guidance for obtaining CDSCO manufacturing licenses for Class A, B, C, and D medical devices.
Regulatory Strategy & Product Classification
Regulatory Strategy & Product Classification
Regulatory Strategy & Product Classification
Assessment of device classification and development of regulatory pathways for India and global markets.
Technical Documentation Preparation
Regulatory Strategy & Product Classification
Technical Documentation Preparation
Preparation and review of Device Master File (DMF), Plant Master File (PMF), and other regulatory documentation.
USFDA Regulatory Consulting
Regulatory Strategy & Product Classification
Technical Documentation Preparation
Support for USFDA regulatory requirements, including regulatory strategy and submission guidance.
CE Marking Support
Regulatory Compliance & Post-Approval Support
Regulatory Compliance & Post-Approval Support
Assistance with documentation and compliance for CE marking under European medical device regulations.
Regulatory Compliance & Post-Approval Support
Regulatory Compliance & Post-Approval Support
Regulatory Compliance & Post-Approval Support
Guidance on regulatory updates, change notifications, and ongoing compliance requirements.
Brazil Regulatory Services (ANVISA)
Regulatory Compliance & Post-Approval Support
Brazil Regulatory Services (ANVISA)
Regulatory consultancy for Brazil medical device approval through ANVISA, including classification, dossier preparation, product registration, GMP compliance, and market authorization support.
