Regulatory and Market-Entry Support for MedTech Businesses
The medical device and diagnostics sector is one of the fastest-growing and most strictly regulated areas in healthcare. From innovative diagnostic instruments to advanced medical devices, every product must meet rigorous compliance standards to ensure patient safety, quality, and market acceptance.
At ELT Corporate, we offer comprehensive regulatory advisory services to help manufacturers, distributors, and healthcare innovators navigate CDSCO, BIS, FSSAI, and international regulations. Our expert team ensures your products are audit-ready, compliant, and prepared for market entry, both in India and globally.
We specialize in end-to-end support, covering product classification, technical documentation, licensing, import/export compliance, and post-market surveillance, providing a complete regulatory roadmap tailored to your device or diagnostic product.
| Document | Explanation |
|---|---|
| Device Specifications | Model, components, intended use, functional description |
| Manufacturing Details | Site details, ISO certifications, quality systems |
| Clinical Data | Trials, literature, predicate device comparisons |
| Risk Management Files | Biocompatibility, electrical safety, ISO 14971 reports |
| Technical Dossiers | DMF, PMF, Essential Principles Checklist |
| Labeling & Packaging | IFU, packaging compliance, warnings |
| Regulatory Forms | MD-5/MD-15, Form 40/41/42, BIS applications |
| Import/Export Documents | Free Sale Certificates, Certificates of Origin, customs clearance document |
Identify device classification and applicable rules. Perform a gap analysis for documentation, testing, and compliance.
Prepare DMF, PMF, CER, risk management files, labeling, and instructions. Ensure technical documentation is audit-ready.
Submit applications to CDSCO, BIS, FSSAI, or international authorities. Handle queries and coordinate with inspectors/laboratories.
Regulatory updates, renewals, compliance audits, adverse event reporting and post-market surveillance planning.
Guidance for obtaining import licenses, Free Sale Certificates, and export documentation. Ensure international shipments meet regulatory requirements.
Technical specifications, clinical data, DMF/PMF, risk files, labeling, and regulatory forms.
Yes, CDSCO mandates licensing for all foreign or SKD devices entering India.
Yes, we provide guidance for EU MDR, US FDA, ASEAN, and Middle East compliance.
Class A/B: 4-6 weeks; Class C/D: 8-12 weeks, depending on documentation and query cycles.
We provide end-to-end regulatory solutions, faster approvals, audit-ready submissions, and global market access guidance.
