CDSCO — Central Drugs Standard Control Organisation, India
Medical devices in India are regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare. The regulatory framework is governed by the Medical Device Rules 2017 (MDR 2017), which replaced the earlier Schedule M (III) provisions under the Drugs and Cosmetics Act 1940.
Under MDR 2017, medical devices are classified into four classes based on risk: Class A (lowest risk), Class B, Class C, and Class D (highest risk). Imported medical devices must be registered in India before they can be commercially supplied. The registration requires an Indian Authorised Agent (AA) who acts as the local regulatory representative for the foreign manufacturer.
The CDSCO's SUGAM online portal is used for all registration applications. Class A and Class B registrations are reviewed at the State Licensing Authority (SLA) level, while Class C and Class D are reviewed at the Central Drug Authority (CDA) level, which involves more rigorous technical review. An Import Licence (Form MD-15) is a mandatory prerequisite for any foreign device to legally enter India.
- Medical Device Rules 2017 (MDR 2017) — primary regulatory framework
- Indian Authorised Agent required for all foreign manufacturers
- Import Licence (Form MD-15) required before first commercial import
- SUGAM portal for all CDSCO registration submissions
- Class A/B: State-level review · Class C/D: Central-level (CDA) review
CDSCO Review Timelines by Device Class
Estimated CDSCO processing times under MDR 2017. Import Licence (Form MD-15) processing runs in parallel and should be initiated at the same time as product registration.
Integrated Services for India CDSCO Registration
CDSCO Device Registration
End-to-end management of Class A–D device registration through the CDSCO SUGAM portal — including MDR 2017-compliant dossier preparation, classification analysis, SLA and CDA submission management, deficiency response, and approval tracking. Full registration lifecycle management from initial classification through certificate issuance.
Authorised Agent & Import Licence
JNPMEDI APAC coordinates your Indian Authorised Agent (AA) appointment — ensuring the AA is independent of your distribution partner so regulatory and commercial roles remain separate. We simultaneously manage the Form MD-15 Import Licence application to ensure commercial readiness aligns with registration approval.
Post-Market & Compliance
Ongoing compliance management under MDR 2017 — adverse event reporting to CDSCO, registration renewal management, product variation submissions, recall and FSCA coordination, and regulatory intelligence on MDR 2017 amendments. Full post-market compliance coverage throughout the commercial lifecycle of your device in India.
Why JNPMEDI APAC for India CDSCO Registration
JNPMEDI APAC has direct regulatory operations in India. Your CDSCO dossiers are managed by our team with direct accountability to you — not subcontracted to an undisclosed local agent. This means faster deficiency response, accurate SUGAM portal management, and a single point of contact across your India and APAC registrations.
The MDR 2017 Authorised Agent is your local regulatory anchor in India. If your AA is also your distributor, changing commercial partners forces a regulatory transfer — triggering a new registration process. JNPMEDI APAC structures the AA independently, protecting your commercial flexibility for the life of your product in India.
India is a major standalone market, but it is also part of a broader APAC strategy for most manufacturers. JNPMEDI APAC coordinates India alongside Singapore, Malaysia, Thailand, Vietnam, and Indonesia — sharing core dossier content, aligning timelines, and managing all market registrations through one accountable platform.
India CDSCO Registration — FAQ
Class A and B devices are reviewed at the State Licensing Authority (SLA) level, while Class C and D devices are reviewed by the Central Drug Authority (CDA). CDA review is more rigorous and involves a separate technical evaluation committee, which is why Class C/D timelines are longer.
MDR 2017 requires an AA for foreign manufacturers regardless of whether they have a local subsidiary. JNPMEDI APAC recommends keeping the AA structurally separate from any commercial entity to protect regulatory continuity if distribution arrangements change.
SUGAM is CDSCO's online platform for all medical device registration submissions, licence renewals, variations, and import licence applications. All MDR 2017 submissions must be filed through SUGAM.
Yes. JNPMEDI APAC coordinates India registrations alongside Singapore, Malaysia, Thailand, and Vietnam. India's regulatory dossier shares significant content with ASEAN CSDT submissions, reducing total preparation time.