Central Drugs Standard Control Organisation (CDSCO)

The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority for drugs, medical devices, and diagnostics under the Directorate General of Health Services, Ministry of Health and Family Welfare. CDSCO and state licensing authorities share responsibilities under the Medical Devices Rules, 2017. Manufacturers entering India should determine both the device class and the competent licensing authority.

What does CDSCO do for medical devices?

CDSCO develops and administers national medical device requirements, handles imported-device licensing and other central-authority functions, coordinates with state regulators, oversees clinical investigations, and supports post-market enforcement. The Drugs Controller General of India leads CDSCO. State licensing authorities handle certain domestic manufacturing and enforcement activities, particularly for lower-risk devices.

How are medical devices classified in India?

India uses Classes A, B, C, and D. Class A devices are low risk and Class D devices are high risk. Classification is based on published lists and rules covering intended purpose, invasiveness, duration of use, active functions, and other characteristics. Classification determines the licensing route, review depth, quality-system expectations, and authority involvement.

What is the import licensing route?

An overseas manufacturer generally appoints an authorized Indian agent that has the appropriate wholesale or manufacturing license. The agent submits the import-license application through CDSCO's SUGAM portal. Under the Medical Devices Rules, Form MD-14 is used for the application and an approved import license is issued in Form MD-15. Device and manufacturing-site details must be correctly included in the license scope.

What documents are usually required?

The application can include a power of attorney, Free Sale Certificate or comparable authorization evidence, plant master file, device master file, quality-management certification, essential-principles checklist, labeling, risk-management and performance evidence, and fees. Requirements depend on class, device type, manufacturing sites, and the evidence available from recognized jurisdictions. Products may also face testing or clinical-investigation requirements.

Is a CDSCO license permanent?

India's current framework uses retention fees to maintain licenses rather than treating every approval as a simple fixed-term registration. License holders must still keep details current, obtain approval or notify changes as applicable, maintain quality-system compliance, and meet vigilance and recall obligations. Businesses should monitor current CDSCO notices because procedures and online workflows evolve.

How do I contact CDSCO or verify current rules?

Use CDSCO's medical devices and diagnostics portal and Medical Devices Rules page for official material. CDSCO lists a medical device helpdesk at helpdesk.md@cdsco.nic.in.

Organisation or Organization?

The authority's official English name uses the British spelling “Organisation.” Searches for “Central Drugs Standard Control Organization” usually refer to the same agency, but formal documents should use the official name.

Related India regulatory topics

See our India medical device registration overview for an end-to-end explanation.