Regulatory Compliance &
Certifications
We handle the documentation complexity so you can focus on patient care. Full support for CDSCO registration, CE marking, ISO 13485, AERB, and import compliance under Indian Medical Devices Rules 2017.
CDSCO Import Process
Device Classification
Determine risk class (A/B/C/D) under MDR 2017 to identify the correct regulatory pathway and documentation requirements.
Importer Registration
Obtain Form MD-14 importer registration with CDSCO Central Licensing Authority. Valid for 5 years, renewable.
Device Registration
File Form MD-15 for each device model. NSC Global prepares the full technical file, clinical evaluation summary, and labelling review.
Quality Audit
Overseas manufacturer undergoes GMP audit by a CDSCO-authorised body. NSC Global coordinates manufacturer liaison and audit scheduling.
Licence Grant
Receive import licence (Form MD-16) valid for 5 years, renewable. Product-specific licence maintained for every restricted device category.
Ongoing Compliance
Post-market surveillance, CDSCO vigilance reporting, adverse event reporting, and periodic renewal management.
Standards We Work With
CE Marking (EU MDR 2017)
European conformity for medical devices sold in EU/EEA markets. Requires Notified Body involvement for Class IIa, IIb, and III devices.
ISO 13485:2016
Quality management system standard specific to medical device manufacturers. NSC Global sources only from certified manufacturers.
IEC 60601 Series
Electrical safety and essential performance standards for medical electrical equipment. Applies to all powered devices.
CDSCO MDR 2017
India's Medical Devices Rules 2017 — the primary regulatory framework for import, manufacture, and sale of medical devices.
FDA 510(k) / PMA
US market pathway via substantial equivalence or premarket approval. Available on premium product lines.
AERB (India)
Atomic Energy Regulatory Board approval required for X-ray, CT, mammography, C-arm, and nuclear medicine equipment in India.
India's Medical Device Regulatory Framework
Understanding the regulatory landscape is essential before importing or distributing medical devices in India. NSC Global navigates this on your behalf.
CDSCO (Central Drugs Standard Control Organisation)
The Central Licensing Authority for medical devices under the Drugs and Cosmetics Act. All medical devices must be registered with CDSCO before import or sale. CDSCO classifies devices into Class A (lowest risk) through Class D (highest risk).
- arrow_rightMD-14: Importer licence application
- arrow_rightMD-15: Device registration per model
- arrow_rightMD-16: Import licence (5-year validity)
- arrow_rightRisk-based classification: Class A/B/C/D
BIS — Bureau of Indian Standards
BIS certification is mandatory for specific product categories including respiratory protective devices (IS 9473), in-vitro diagnostic devices, and sterilisation equipment. Non-certified products face market withdrawal and legal liability.
- arrow_rightIS 9473: N95/respirator mandatory certification
- arrow_rightISD 13878:2020: Respiratory device alignment standard
- arrow_rightMandatory for import and domestic sale
- arrow_rightLegal liability for non-certified products
Legal Metrology Act & Drug Rules
Medical devices must comply with Legal Metrology (Packaged Commodities) Rules for labelling. Drugs & Cosmetics Rules specify storage, handling, and distribution requirements for Class III/IV devices.
- arrow_rightLabelling in English and regional languages
- arrow_rightNet quantity, expiry, storage conditions mandatory
- arrow_rightUnique Device Identification (UDI) implementation
- arrow_rightPost-market surveillance obligations
NSC Global Compliance Commitment
- check_circleAll supplies meet NABL-accredited test reports — calibration certificates traceable to national standards
- check_circleProduct-specific import licences (MD-14/MD-15) maintained for all restricted and notified device categories
- check_circleVendor audit programme — annual GMP audits of all tier-1 suppliers with corrective action tracking
- check_circlePost-market surveillance reporting — adverse event forms submitted to CDSCO within mandatory timelines
- check_circleTechnical file maintenance — Design History Files and Technical Files retained for 10 years post-last supply
- check_circleLabelling compliance review — all product labels reviewed against MDR 2017 Schedule requirements before import
Documents We Prepare for You
MD-15 Technical File
Complete device description, intended purpose, risk analysis, clinical evaluation, and labelling review per MDR 2017 Schedule.
GMP Certificate
Manufacturer's Good Manufacturing Practice certificate, verified with CDSCO-authorised inspection body.
Clinical Data Summary
Literature review or clinical investigation results supporting safety and performance claims.
Post-Market Surveillance
PSUR template, complaint handling SOP, and vigilance reporting workflow to CDSCO.
Certifications & Accreditations
All products and processes at NSC Global meet the following standards. Certificates available on request for each device category.
Documents NSC Global Prepares for CDSCO Import
MD-15 Technical File
Complete device description, intended purpose, risk analysis, clinical evaluation, and labelling.
GMP Certificate
Manufacturer's good manufacturing practice certificate, verified with CDSCO-authorised body.
Clinical Data Summary
Literature review or clinical investigation results supporting safety and performance claims.
IFU & Labelling Review
Instructions for use and labelling reviewed against CDSCO language and content requirements.
Risk Management File
ISO 14971 risk analysis, risk control measures, and residual risk acceptance documentation.
Post-Market Surveillance
PSUR template, complaint handling procedure, and CDSCO vigilance reporting workflow.
Need compliance guidance?
Our regulatory team will assess your device, determine the risk class, and prepare the full CDSCO documentation package — MD-14, MD-15, technical file, and manufacturer liaison.
Contact Our Regulatory Team →