Question 1

What is CDSCO and why is it important for medical device manufacturers?

Accepted Answer

The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority for pharmaceuticals and medical devices, headed by the Drugs Controller General of India (DCGI). CDSCO enforces the Medical Device Rules 2017 (MDR 2017), which established a comprehensive regulatory framework for medical devices in India. All medical devices marketed in India require registration with CDSCO, and foreign manufacturers must obtain import licenses and designate an Indian Authorized Agent. CDSCO is modernizing regulations to align with international standards while addressing India's unique healthcare needs.

Question 2

What are the Medical Device Rules 2017 (MDR 2017)?

Accepted Answer

The Medical Device Rules 2017 (MDR 2017) established India's first comprehensive regulatory framework for medical devices, replacing the previous limited regulations. Key Provisions: Risk-based classification system (Class A, B, C, D), mandatory device registration and manufacturer licensing, import license requirements for foreign devices, quality management system requirements (ISO 13485), clinical investigation requirements for certain devices, post-market surveillance and adverse event reporting, Indian Authorized Agent requirements for foreign manufacturers. Implementation: Phased implementation with Class A/B devices registered first, Class C/D devices followed, IVDs have separate implementation timeline. MDR 2017 aims to improve device quality, patient safety, and align India with global regulatory practices.

Question 3

How does India classify medical devices?

Accepted Answer

India uses a risk-based classification system under MDR 2017: Class A: Low risk (e.g., manual surgical instruments, non-invasive devices), Class B: Low-moderate risk (e.g., hypodermic needles, suction apparatus), Class C: Moderate-high risk (e.g., lung ventilators, orthopedic implants), Class D: High risk (e.g., heart valves, implantable defibrillators, drug-eluting stents). Classification is based on: invasiveness, duration of contact, whether device is active or has a measuring function, interaction with medicines or body tissues, intended purpose and critical nature. Higher class devices face more stringent registration requirements, mandatory clinical investigations, and longer review timelines.

Question 4

What is an Indian Authorized Agent and what are their responsibilities?

Accepted Answer

An Indian Authorized Agent (also called Authorized Agent for Import or Authorized Representative) is a person or legal entity domiciled in India designated by a foreign medical device manufacturer to act as their representative with CDSCO. Requirements: Must be domiciled in India with valid business registration, registered with CDSCO for the specific device(s), Responsibilities: Submit registration applications (Form MD-17) and import license applications (Form MD-18) to CDSCO, maintain technical documentation and quality certificates, serve as liaison between foreign manufacturer and CDSCO, handle post-market surveillance and adverse event reporting (via medical device database PRISM), coordinate product recalls and corrective actions. An Indian Authorized Agent is mandatory for all foreign manufacturers seeking to import and market devices in India.

Question 5

What are the registration and import license requirements in India?

Accepted Answer

Foreign medical device manufacturers must obtain both device registration and import licenses: Registration Certificate (Form MD-17): Manufacturer registration with CDSCO, requires quality certificate (ISO 13485 or equivalent), free sale certificate from country of origin, valid for 5 years. Import License (Form MD-18): Required for each device model or family, device classification and technical documentation, regulatory approval from country of origin (CE, FDA, TGA, etc.), labeling and instructions for use, valid for 3 years (renewable). Additional Requirements: Indian Authorized Agent designation, payment of prescribed fees, for Class C/D devices: clinical investigation data or exemption justification. Processing timelines vary from 3-12 months depending on device class and completeness of application.

Question 6

What quality certificates does CDSCO accept?

Accepted Answer

CDSCO requires evidence of quality management system compliance for device registration. Acceptable Certificates: ISO 13485 certification (most common and preferred), CE marking certificate (indicates ISO 13485 compliance), FDA establishment registration and device listing, WHO-GMP certificate, certificates from other recognized regulatory authorities. Certificate Requirements: Must be current and valid, issued by accredited certification body, cover the specific manufacturing site(s), include the device model(s) being registered. Free Sale Certificate: Certificate from country of origin confirming device is freely marketed (required in addition to quality certificate). ISO 13485 is strongly recommended as the standard quality certificate for Indian market access.

Question 7

How often is India CDSCO regulatory news updated and how can I stay informed?

Accepted Answer

CDSCO regularly publishes notifications, guidance documents, and regulatory updates related to MDR 2017 implementation, new device classifications, and post-market surveillance requirements. Recent focus includes expanding device coverage, digitalization (e.g., PRISM database for adverse events), and alignment with international standards. Our platform aggregates daily updates from 7 premium commercial sources including RAPS, Emergo by UL, Citeline, and Pacific Bridge Medical. We recommend checking this page regularly and working closely with your Indian Authorized Agent to monitor CDSCO announcements.

Question 8

What commercial sources does this platform use for India news?

Accepted Answer

We aggregate Indian regulatory intelligence from 7 premium sources: RAPS (Regulatory Affairs Professionals Society), Emergo by UL, Citeline MedTech Insight, Pacific Bridge Medical, Asia Actual, Pure Global's proprietary research, and Qualtechs. These sources provide expert analysis, real-time updates, and strategic insights beyond basic CDSCO announcements, helping you navigate MDR 2017 compliance, registration and import licensing, Indian Authorized Agent selection, and quality certification requirements.

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