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Central Drugs Standard Control Organisation
The Medical Devices Rules 2017 regulate every stage of the medical device supply chain in India — manufacturing, import, testing, wholesale, and retail. With four risk classes and over a dozen licence types, the regulatory matrix is complex. S.K. Enterprises provides end-to-end support: from device classification and technical dossier preparation through to Central and State licence grants, and ISO 13485 quality management system implementation.
Overview
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Share your requirement and we'll prepare a clear action plan — timeline, documentation checklist, and cost estimate.
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Issued by the State Licensing Authority (SLA) for low and moderate-risk medical devices, including syringes, bandages, thermometers, and most diagnostic equipment.
High and critical-risk devices (implants, ICDs, ventilators). Requires Central Licensing Authority (CDSCO) approval, full GMP audit, and clinical evidence.
Allows a brand owner without its own manufacturing facility to make devices at a licensed contract manufacturer's premises, subject to QMS compliance.
Required for importing Class A/B (MD-14) and Class C/D (MD-15) devices. Foreign manufacturers must appoint an Authorised Indian Agent (AIA).
For importing or manufacturing devices solely for testing, R&D, or clinical investigation, without commercial sale.
State-level distribution licences for wholesalers and retailers of medical devices, obtained from the respective State Licensing Authority.
For devices not previously approved in India, requiring CDSCO clinical investigation approval and new device registration before commercial sale.
ISO 13485:2016 quality management system gap analysis, documentation, internal audits, and certification readiness — mandatory for Class C & D devices.
Process
We classify your device under Schedule II of the Medical Devices Rules (Class A–D) based on intended use, invasiveness, and duration of contact. Classification determines the licence type and the approving authority (State or Central).
We prepare the complete technical submission: device description, performance data, biocompatibility assessment, clinical evaluation summary, GMP compliance documents, and ISO 13485 status.
We submit on the SUGAM portal for Central licences or through the State Drug Controller for State licences, managing acknowledgements and paying applicable government fees.
CDSCO and SLAs routinely raise additional queries. We respond to all deficiency letters, schedule inspections, and liaise with the authority until approval is issued.
Once granted, we deliver all original documents, log renewal dates in our CRM, and alert you in advance — licences that lapse require fresh applications rather than renewals.
Documents
Company / firm registration & PAN documents
Device description, intended use, and technical specifications
Biocompatibility data / risk analysis report
Performance testing reports (NABL-accredited lab)
GMP compliance certificate or ISO 13485 certificate
Authorised Indian Agent appointment letter
Import applications only
Clinical evaluation / literature review
Required for Class C & D
Labelling / IFU draft
We guide you through document preparation, certification of copies, and formatting requirements specific to each authority.
FAQ
Product Testing
Lab coordination for civil, electrical, electronics, mechanical, chemical, and biological product testing against IS and international standards.
BIS Certification
ISI Mark, FMCS, Hallmark Registration & CRS for electronics — full certification lifecycle management.
FSSAI / AYUSH / Drug
FSSAI state & central licences, AYUSH manufacturing licences, cosmetic licences (COS-1/2/8), and wholesale drug licences for India.
Tell us what you need — we'll assess your requirements and come back with a clear action plan. No jargon, no obligation.