End-to-end regulatory advisory for Class A, B, C, and D diagnostic and medical instruments under the Central Drugs Standard Control Organization (CDSCO). We handle Indian Authorized Agent (IAA) appointment, SUGAM portal filing, MD-14/MD-15 import licences, and QMS ISO 13485 conformity.
Medical Device Rules 2017
Approved Licences Issued
Drug Controller General of India (DCGI)
SUGAM Portal Online Filing
The medical device regulatory landscape in India is governed by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, headed by the Drug Controller General of India (DCGI).
Governed by the Medical Device Rules (MDR), 2017, the licensing regime has fully transitioned into a mandatory licensing structure. All domestic manufacturers and foreign exporters must secure official CDSCO approvals prior to importing, distributing, or commercializing medical and in-vitro diagnostic (IVD) devices in India.
All regulatory submissions, fees, and evaluations are managed electronically through the central SUGAM Portal (cdscoonline.gov.in).
Marketing or importing unregistered medical devices in India is an offense punishable by shipment seizure, port confiscation, and prosecution under the Drugs & Cosmetics Act. A valid Form MD-15 (for imports) or Form MD-9 (for manufacturing) is mandatory.
The Medical Device Rules (MDR) 2017 classify instruments into four categories based on risk parameters, invasiveness, and clinical duration:
Non-invasive devices without active energy sources.
Authority: State Licensing Authority (SLA) / Fast-Track
Invasive short-term instruments and powered diagnostic meters.
Authority: State Licensing Authority / Notified Body Audit
Critical care monitoring, surgical implants, and radiation devices.
Authority: Central Licensing Authority (CDSCO Headquarters)
Life-supporting, implantable, or complex cardiovascular systems.
Authority: CDSCO + Subject Expert Committee (SEC)
| Device Class | Licensing Authority | Domestic Manufacture Form | Overseas Import Form | Audit / Scrutiny Route |
|---|---|---|---|---|
| Class A (Low) | State Licensing Authority (SLA) | MD-3 (App) / MD-5 (Grant) | MD-14 (App) / MD-15 (Grant) | Self-declaration & Fast Track |
| Class B (Low-Moderate) | State Licensing Authority (SLA) | MD-3 (App) / MD-5 (Grant) | MD-14 (App) / MD-15 (Grant) | Notified Body Inspection |
| Class C (Moderate-High) | Central Licensing Authority (CLA) | MD-7 (App) / MD-9 (Grant) | MD-14 (App) / MD-15 (Grant) | CDSCO Central Medical Device Officer |
| Class D (High) | Central Licensing Authority (CLA) | MD-7 (App) / MD-9 (Grant) | MD-14 (App) / MD-15 (Grant) | Subject Expert Committee (SEC) + Clinical Data |
Foreign manufacturers without a legal registered corporate presence in India must appoint an Indian Authorized Agent (IAA). The IAA acts as the legal liaison between the foreign brand and CDSCO authorities.
Statutory Requirements for an IAA:
Maanak Consultancy IAA Representation
We provide full-scope, compliant Indian Authorized Agent representation for international medical technology brands, managing your SUGAM portal filings and regulatory audit communications.
Determine accurate risk category (Class A–D) under Medical Device Rules 2017 to ascertain exact forms, testing requirements, and government fee brackets.
Execution and apostille/notarization of legal Power of Attorney granting IAA authority to submit dossiers on the SUGAM portal.
Compilation of technical files, ISO 13485 QMS certification, Free Sale Certificate (FSC), clinical evaluation, and labeling compliance.
Digital upload of application dossier and settlement of statutory government fees via the central CDSCO gateway.
Receipt of the official Form MD-15 import licence valid for 5 years, enabling customs clearance and nationwide hospital distribution.
Device description, design specifications, material characterization, biocompatibility, software validation, and shelf-life data.
Manufacturing site profile, clean room environmental controls, personnel qualification, and sterilization validation reports.
Valid ISO 13485 QMS certification plus FSC from national health authority of the country of origin (US FDA, CE, PMDA).
Labels compliant with Indian MDR rules, bilingual warnings, batch coding, and Instructions for Use in English.
Talk to our lead medical device regulatory auditor within 15 minutes.