Medical Device Regulatory Services in India
From risk-based Class A–D classification and SUGAM online portal filings to Authorized Indian Representative (AIR) representation, Central & State FDA manufacturing licenses, and clinical investigation permissions—NKB Regovanta delivers seamless market access across India.
Navigating the Modern Medical Device Landscape in India
Medical devices in India are governed under the Drugs and Cosmetics Act, 1940 and the comprehensive Medical Devices Rules, 2017 (MDR 2017). With progressive regulatory transitions and the mandatory registration of all medical devices under CDSCO notifications, India enforces stringent risk-based controls to ensure safety, quality, and clinical performance.
Under the MDR 2017 framework, products are classified into four risk categories: Class A, B, C, and D. Approvals are distributed between the State Licensing Authorities (SLA) for Class A and B manufacturing, and the Central Licensing Authority (CDSCO Headquarters, New Delhi) for Class C and D manufacturing, clinical trials, and all import licensing.
What is a "New Device – First Time in India"?
As per CDSCO MDR 2017 rules, a medical device is designated as a "New Device" if neither the device itself nor a substantially equivalent predicate device is currently approved and registered in India. Additionally, approved devices introducing new therapeutic indications, altered raw materials, modified energy mechanisms, or novel software algorithms are also classified as new devices requiring specialized technical evaluation and clinical investigation.
Why NKB Regovanta?
- End-to-End SUGAM Management: Complete digital dossier preparation, upload, and fee optimization.
- Authorized Indian Representative: Holding active wholesale drug and medical device distribution licenses (Form 20B/21B).
- Technical File & Gap Audit: ISO 13485 QMS alignment, Device Master File (DMF), and Plant Master File (PMF) curation.
- Subject Expert Committee (SEC) Defense: Dedicated technical liaison for novel device clinical investigations and MDAC panels.
Classification of Medical Devices in India
CDSCO classifies medical devices into four risk parameters, dictating whether licensing authority lies with State FDAs or Central CDSCO Headquarters.
Non-Invasive / Diagnostic
Simple devices with minimal direct biological risk. Most Class A non-sterile devices follow an expedited self-declaration / online registration pathway.
• Surgical dressings, alcohol swabs, cotton wool
• Digital & infrared thermometers
• Examination gloves & manual wheelchairs
Invasive / Short-Term Use
Devices interacting with body cavities or skin barriers for limited duration. Requires Notified Body audit verification.
• Hypodermic needles & blood transfusion sets
• Suction pumps & anesthesia breathing circuits
• Dental filling materials & surgical drapes
Implantable / Active Systems
Surgically invasive devices or active diagnostic hardware requiring extensive clinical evidence and CLA inspection.
• Hemodialysis machines & dialyzers
• Mechanical lung ventilators
• Orthopedic bone fixation plates & screws
Life-Supporting / Critical
Permanent implants, cardiovascular, neurological, or life-sustaining technologies subject to supreme regulatory scrutiny.
• Coronary drug-eluting stents & heart valves
• Implantable cardiac pacemakers & ICDs
• Neurological deep brain stimulators & vascular grafts
Overview of Statutory Application & Grant Forms
The Central Drugs Standard Control Organization specifies distinct statutory forms for importers and domestic manufacturers based on device class and operational intent.
Existing / Predicate Medical Devices
Standard Pathway| Applicant | Risk / Class | Type of License | Statutory Forms |
|---|---|---|---|
| Importer | Class A, B, C, D | Importer License | Application: MD-14|Permission: MD-15 |
| Manufacturer | Class A, B | Manufacturing License (SLA) | Application: MD-3|Permission: MD-5 |
| Class A, B | Loan License (SLA) | Application: MD-4|Permission: MD-6 | |
| Manufacturer | Class C, D | Manufacturing License (CLA) | Application: MD-7|Permission: MD-9 |
| Class C, D | Loan License (CLA) | Application: MD-8|Permission: MD-10 |
New Medical Devices (Without Predicate)
Special CLA Filings| Applicant | Risk / Class | Type of License / Filing | Statutory Forms |
|---|---|---|---|
| Importer | Class A, B, C, D | Clinical Investigation Permission | Application: MD-22|Permission: MD-23 |
| Class A, B, C, D | New Device Import Permission | Application: MD-26|Permission: MD-27 | |
| Class A, B, C, D | Test License for Import | Application: MD-16|Permission: MD-17 | |
| Manufacturer | Class A, B, C, D | Clinical Investigation Permission | Application: MD-22|Permission: MD-23 |
| Class A, B, C, D | New Device Mfg Permission | Application: MD-26|Permission: MD-27 | |
| Class A, B, C, D | Test License for Manufacturing | Application: MD-12|Permission: MD-13 |
Regulatory Pathway for Medical Device Importers
Foreign manufacturers cannot file applications directly to CDSCO and must appoint a legally recognized Authorized Indian Representative (AIR) holding a valid Wholesale License.
Classification & Predicate Review
Determine device risk (Class A, B, C, or D), verify CDSCO notified lists, and establish predicate equivalence.
AIR Appointment & Form 9
Execute Power of Attorney (PoA) and Form 9 authorization naming NKB Regovanta as your in-country representative.
SUGAM Application Filing (MD-14)
Compile Plant Master File, Device Master File, ISO 13485 certificate, and Free Sale Certificate (FSC) for submission.
Grant of Import License (MD-15)
CDSCO evaluation, response to technical queries, and issuance of perpetual Form MD-15 import license.
Authorized Indian Representative (AIR) & Registration Holder Support
Under the Medical Device Rules, 2017, non-Indian medical device manufacturers must appoint an authorized agent residing in India who possesses a valid wholesale drug license (Form 20B/21B) issued by the State Licensing Authority. The AIR is legally responsible for regulatory compliance, product traceability, post-market vigilance, and handling communications with CDSCO.
Manufacturing & Loan Licensing Framework
Manufacturing approvals in India are bifurcated between State Licensing Authorities (Class A & B) and Central Licensing Authorities (Class C & D), requiring stringent plant layout audits and ISO 13485 conformity.
State FDA Manufacturing (Form MD-5) & Loan Licensing (Form MD-6)
Licensing for Class A (Low Risk) and Class B (Low-to-Moderate Risk) manufacturing falls under the jurisdiction of respective State Licensing Authorities (SLA / State FDA). Applications are submitted via Form MD-3 (for manufacturing) or Form MD-4 (for loan licensing), followed by a mandatory third-party Notified Body audit before the grant of Form MD-5 or Form MD-6.
Investigational New Device & Clinical Evaluation
For innovative medical technologies without predicate devices in India, demonstrating clinical safety and performance under CDSCO GCP guidelines is mandatory.
Generally exempted from conducting local clinical investigations in India, provided safety, bench testing, and published clinical literature satisfy the licensing authority.
Devices lacking Free Sale Certificates (FSC) from recognized GHTF countries (USA, EU, Canada, Japan, Australia) or introducing novel clinical claims must conduct human clinical investigations in India.
Permission to Conduct Clinical Investigation (Form MD-22 & MD-23)
Filing under Form MD-22 requires an Investigator’s Brochure, Clinical Investigation Protocol (CIP), Informed Consent Forms (ICF), Ethics Committee (EC) approvals, and pre-clinical animal safety data. Upon favorable recommendation by the Subject Expert Committee (SEC), CDSCO issues Form MD-23.
Full Spectrum CDSCO Medical Device Services
Explore specialized regulatory, quality assurance, and commercial import licensing services managed by NKB Regovanta.
Import License (Form MD-14 & Form MD-15)
Complete preparation of Plant Master Files (PMF) and Device Master Files (DMF) for commercial import registration of Class A, B, C, and D medical devices.
New Medical Device License (Form MD-26 & MD-27)
Statutory applications for devices without existing predicates in India, steering technical justification through CDSCO expert committees.
Test License for Medical Devices (MD-16 / MD-17)
Procure fast-track permission to import or manufacture small device quantities for testing, lab evaluations, clinical trials, or demonstrations.
Non-Notified Devices Registration (Form MD-42)
Assistance with registration numbers for devices under transition timelines, ensuring uninterrupted commercial distribution across India.
Authorized Agent (AIR) Support in India
Act as your neutral regulatory holder in India holding active Form 20B/21B wholesale drug distribution licenses and managing all CDSCO filings.
ISO 13485 Certification Assistance
Establish, audit, and maintain a robust ISO 13485:2016 quality management system aligned with MDR 2017 Fifth Schedule specifications.
PC-PNDT Certificate (Form A & Form B)
Statutory registration for ultrasound and diagnostic imaging equipment manufacturers, importers, and maintenance service providers.
WPC ETA Approval & Wireless Framework
Equipment Type Approval (ETA) and Import Licenses for Bluetooth, Wi-Fi, telemetry, and IoT wireless medical technologies via Saral Sanchar.
Free Sale Certificate (FSC) & Export NOC
Procure Free Sale Certificates from CDSCO for Indian manufactured medical devices to expedite global market authorizations abroad.
The Indian Ministry of Consumer Affairs & CDSCO Import Framework for Infrared Thermometers
In response to surging nationwide requirements for non-contact temperature screening, the Ministry of Consumer Affairs and the Central Drugs Standard Control Organization (CDSCO) introduced calibrated relaxations for the import and clearance of infrared thermometers.
Key Compliance Takeaways for Importers:
• Legal Metrology Exemptions: Streamlined customs verification with expedited No-Objection Certificates (NOC) for non-contact thermal monitoring devices.
• MDR 2017 Class A / Class B Categorization: Ensuring compliance with mandatory clinical accuracy benchmarks (ASTM E1965 / ISO 80601-2-56).
• Labeling & UDI Directives: Clear specification of measuring range, operating ambient temperature, calibration certificates, and Indian AIR contact details.
NKB Regovanta assists diagnostic equipment manufacturers and importers in securing regulatory clearances, Legal Metrology declarations, and CDSCO compliance for all temperature monitoring and vital sign screening devices.
Initiate Your Medical Device Filing with NKB Regovanta
Whether you need assistance with an urgent Form MD-14 import submission, ISO 13485 QMS audit, or Authorized Indian Representative appointment, our senior regulatory strategists are ready to assist.