Established by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.
CDSCO regulates:
- Approval of medical devices
- Quality control standards
- Import licensing
- Safety monitoring
- Device registration and classification
Earlier, imported medical devices could be sold without stringent oversight. However, since 2006—and reinforced under the Medical Device Rules, 2017—every medical device entering the Indian market must comply with CDSCO’s regulatory framework.
Importers dealing in Class A, B, C, or D medical devices must obtain a CDSCO Import License or face suspension, penalties, or cancellation of import rights. The process is mandatory for all overseas manufacturers, their agents, and Indian distributors engaged in medical device imports.
At Global Consulting Services (GCS), we simplify CDSCO registration with end-to-end compliance support, ensuring your devices meet Indian regulatory expectations on time.
- Brand Name / Generic Name
- Intended Use
- Materials of Construction
- Mode of Application / Use
- Risk-based Classification under CDSCO guidelines
- Technical device specifications
This foundational data ensures accurate classification and registration of your medical device.
Domestic medical device manufacturers
Medical device importers and distributors
Foreign manufacturers selling into India
Authorized Indian agents appointed by foreign manufacturers
Indian subsidiaries of foreign medical device companies
GCS supports all applicant categories, including foreign entities needing Indian representation.
Central Drugs and Cosmetics Act, 1940
Medical Device Rules, 2017
Entities holding wholesale licenses such as Form 20/21B or registration certificate Form 41/42 can apply for medical device import rights.
Foreign manufacturers must appoint an Indian authorized agent who:
- Holds a valid wholesale or distribution license
- Handles registration and post-approval compliance
- Liaises with CDSCO on behalf of the manufacturer
Import licenses issued are valid for 5 years.
- India ranks as the 4th largest medical device market in Asia (~USD 12 billion)
- 75–80% of India’s demand is met through imports
- The IVD market is set to reach USD 2,060 million by 2027, growing at 7.5% CAGR
- Cosmetic device imports are rising sharply, estimated at USD 60 million with 4.2% CAGR
Growing healthcare awareness, improved living standards, R&D progression, and increasing clinical infrastructure offer substantial opportunities for both manufacturing and import businesses.
- Authorizes lawful device imports and market entry
- Builds credibility and consumer trust
- Guarantees product safety and performance compliance
- Reduces litigation, penalties, and risk of bans
- Enables access to advanced international markets
- Facilitates long-term business scalability
- 1. Medical Devices Registration
- 2. Medical Device Import License
- 3. IVD Manufacturing License
- 4. IVD Import License
- 5. Cosmetic Import License
- Applicants must register on the CDSCO online portal
- Applications for import licenses are submitted through Form MD-14
- Authorized distributors or agents filing must hold Form 20/21B or Form 41/42
Procedure:
- Online submission
- Upload supporting documents
- Review by CDSCO
Approval or notification of corrections
- Device-specific data — brand, intended use, classification, specifications — is submitted
- Upload mandatory documents such as:
- European CE Certificate
- Free Sale Certificate
- ISO 13485
- Device Master File
- Plant Master File
- European CE Certificate
- CDSCO fees are paid based on device class and purpose
Application number and fee challan are generated
- CDSCO verifies details and documents
- Clarifications or deficiency notes may be raised
- Corrections or justifications must be uploaded online
- Once compliance suffices, CDSCO approves the application
- Import license is issued
- Legal authorization to sell imported devices in India
- Trust enhancement among hospitals, distributors, and consumers
- Competitive advantage and brand reputation
- Reduced regulatory risk and audit complications
- Streamlined access to India’s rapidly expanding healthcare market
Our Expertise Covers:
- Regulatory classification & device evaluation
- Preparation of Device Master File / Plant Master File
- Technical document drafting
- Indian authorized agent support for foreign manufacturers
Post-licensing compliance and audit assistance
- 10+ years of compliance and regulatory experience
- Dedicated medical device regulatory experts
- Faster approvals and minimized procedural delays
- Transparent guidance and structured implementation
- End-to-end service—from consultation to certification
Frequently Asked Questions (FAQs) – BIS Registration / BIS Certification
You must obtain a CDSCO import license by submitting an application along with mandatory documentation. Contact GCS for expert guidance on approval.
Fees vary depending on risk classification (Class A–D). Speak to GCS for a cost-effective process for your specific device category.
Applications are filed via the CDSCO online portal using Form MD-14, along with supporting regulatory documents.
Form MD-14 is the official application form for obtaining CDSCO medical device import licenses, submitted by authorized Indian distributors or agents.
MD-15 is the final import license issued by CDSCO, valid for five years, permitting commercial distribution of medical devices in India.