Medical Device Regulatory Services

The Medical Device Rules (MDR), 2017 regulate the manufacture, import, sale and clinical investigation of medical devices and in vitro diagnostic (IVD) devices in India. Medical devices are classified into Class A, B, C and D depending upon risk. Compliance with MDR 2017, Quality Management Systems and CDSCO requirements is essential before a device can be legally marketed.

Vaayath provides complete regulatory consulting from device classification through licensing, technical documentation, audits and post-approval compliance.

What we deliver

• Device Risk Classification — Accurate classification of your medical device or IVD under CDSCO guidelines (Class A/B/C/D).
• Import Licence (MD-14/MD-15) — Application filing and approval coordination for overseas manufacturers and importers.
• Manufacturing Licence (MD-3/5/7/9) — State and Central licensing support for domestic manufacturing units.
• Quality Management System (ISO 13485) — GAP assessment, Audit readiness and QMS preparation aligned with MDR standards.
• Preparation of Technical documentation — Device Master File, Plant Master File, Risk Management File, Labelling, IFU etc.
• Regulatory Strategy — Determine approval pathway, Predicate evaluation, Licensing timelines, Regulatory feasibility.
• Labelling Compliance — Verification of Medical Device Labels to check if they are complying with the requirements of Medical Device Rules, 2017 and Legal Metrology.

Our Approach

Who this is for

We assist regulatory approvals for:

Our expertise covers a wide range of medical devices and diagnostics, including:

Why Choose Vaayath

• 20+ Years of Regulatory Experience
• Experience across Class A–D Devices
• End-to-End Documentation Support
• Import & Manufacturing Licensing
• ISO 13485 Consulting
• Regulatory Gap Assessments
• Pan India Regulatory Support