Medical Device Registration (Class A/B & C)
Compliance licensing for low, moderate, and high-risk medical hardware and diagnostics.
Regulatory Approval for Medical Devices Across All Risk Categories
The classification of medical devices determines the complexity of your regulatory strategy. Class A, Class B, Class C, and Class D devices require different levels of documentation, clinical validation, and manufacturing audits. At ADMFES, we guide manufacturers and importers through the Medical Device Rules. We are recognized as the best provider for medical device registration (Class A/B & C) services, securing manufacturing and import licenses efficiently.
We manage the compilation of the Device Master File (DMF), site master files, performance evaluation reports (PER) for IVD devices, ISO 13485 alignment, and CDSCO portal uploads. Our team has a 100% success rate in regulatory submissions.
The Best Provider for Device Registration
Prepare dossiers matching CDSCO, FDA 510(k), and CE MDR requirements to launch medical technologies globally.
Our Medical Device Compliance Scope
We offer comprehensive support matching the specific risk class of your device portfolio:
Class A (Low Risk) Devices
Manage portal self-declaration listings, importer licensing, and label review.
Class B (Low-Moderate Risk) Devices
Compile technical files, verify bio-compatibility profiles, and process manufacturing approvals.
Class C & D (High Risk) Devices
Draft comprehensive Device Master Files (DMF), coordinate clinical studies, and resolve audit reviews.
IVD Diagnostic Clearances
Register In-Vitro Diagnostic kits, control materials, and laboratory hardware with health regulators.
Ensure CDSCO MDR 2017 Compliance
In India, all medical devices are regulated under the Medical Device Rules (MDR) 2017. Navigating this framework requires coordination with Central Licensing Authority (CLA) for Class C/D and State Licensing Authority (SLA) for Class A/B. ADMFES provides end-to-end representation, preventing application rejections.
Register Device
Specify device risk classification to get an estimate on audit and dossier preparation.
Regulatory Services
- Regulatory Consulting
- Dossier Preparation & Compilation
- Due Diligence (Pre assessment)
- Gap Analysis
- Health Authority Communication
- Marketing Authorisation (MAA)
- FSSAI & Cosmetic Registration
- Medical Device Registration
- CDSCO India Registration
- Import License Application
- Indian Authorised Agent (IAA)