Medical Device Approvals & Compliance in India

Artexa guides approvals across all risk classes and clinical domains under the Medical Devices Rules.

Surgical & Implant Specialties

Imaging, SaMD & Respiratory

Renal, Rehab & Hospital Equipment

Approvals for orthopaedics, cardiovascular stents, dental implants, ENT instruments, dermatological systems, and plastic surgery devices.

Classification and registration for Software as a Medical Device, AI diagnostics, CT/MRI, interventional radiology, and respiratory care.

Regulatory support for nephrology systems, ophthalmic gear, gynecology, physical support, PPE, and general hospital supplies.

Technical File & File Preparation

Classification & Predicates

DMF, PMF & SDLC Dossiers

CER, Testing & Labeling

Establishing risk classification, grouping logic, and predicate device identification under Medical Devices Rules.

Drafting complete Device Master Files, Plant Master Files, ISO 14971 Risk Management files, and SDLC software documentation.

Compiling Clinical Evaluation Reports, PSUR files, IFU drafts, compliant artwork, UDI integration, and V&V testing protocols.

Licensing & Vigilance Services

Domestic Manufacturing Licenses

Authorised Representative & Import Licensing

Complete licensing support for domestic manufacturing facilities, plant audits, and test licenses for clinical investigations.

Full Indian Authorised Representative representation for overseas manufacturers, managing Form MD-14 import licenses, test licenses, and CDSCO portal registrations.

Post-Market Surveillance & Reporting

Ongoing vigilance, post-market surveillance implementation, and timely adverse event reporting to Indian regulatory authorities.

Reach out for medical device classification, dossier preparation, or legal representation in India.