When it comes to medical device compliance and import licensing, Om Garuda Group stands out as one of the most reliable names in India. As a trusted CDSCO Consultant, we provide complete assistance for product registration, import licenses, and regulatory documentation under the guidelines of the Central Drugs Standard Control Organization (CDSCO). Our CDSCO consultants goal is to simplify the complex approval process so that medical device manufacturers and importers can focus on innovation while staying 100% compliant.
What is CDSCO & Why You Need a CDSCO Consultant?
CDSCO (Central Drugs Standard Control Organization) operates under the Ministry of Health & Family Welfare, Government of India. It regulates the import, manufacture, sale, and distribution of drugs & medical devices across the country. To sell or distribute a medical device legally in India, manufacturers or importers must obtain approval or registration from CDSCO.
Many businesses struggle to understand documentation requirements, approval categories, or device classifications, that’s where a professional CDSCO Consultant like Om Garuda Group helps. We provide end-to-end consultancy for:
- Medical device registration under CDSCO
- Import licenses (Form MD-15, MD-14)
- Authorized Indian agent representation for foreign manufacturers
- Post-approval compliance & renewals
- Technical file preparation as per Indian MDR (Medical Device Rules) 2017
Our team ensures every document and form is prepared as per the latest CDSCO notifications & requirements.
Role of Om Garuda Group as a CDSCO Consultant
Om Garuda Group has years of experience in handling complex regulatory processes for Indian and international clients. As your CDSCO Consultant, our experts manage everything from start to finish, ensuring that your submission meets all technical and legal standards. Our role includes:
- Product classification assessment
- Preparation of Device Master File (DMF) & Plant Master File (PMF)
- Application filing on the SUGAM portal
- Coordination with CDSCO officials for approvals
- Importer & manufacturer license support
- Quality Management System (QMS) compliance as per ISO 13485
We don’t just assist with paperwork; we provide regulatory strategy, technical validation, and hands-on guidance at every stage.
Documents Required for CDSCO Registration
Here’s a quick checklist of documents required for product registration:
- Application form (MD-14 / MD-15)
- Power of Attorney for Authorized Indian Agent
- ISO 13485 certificate
- Device Master File (DMF)
- Plant Master File (PMF)
- Free Sale Certificate (FSC)
- Label artwork & product information leaflet
- Undertaking for post-market surveillance
Missing or incorrect documentation can delay approval. Our CDSCO Consultant team verifies every file to ensure compliance with the latest guidelines.
Benefits of Hiring a CDSCO Consultant
Working with a professional CDSCO Consultant saves time, avoids costly errors, and ensures smooth communication with the regulatory body. Some major benefits include:
- Accurate classification & documentation
- Guidance on compliance with Indian Medical Device Rules (MDR) 2017
- Hassle-free approval process
- Fast turnaround time
- Complete post-approval support
- Compliance with import & distribution norms
With Om Garuda Group as your CDSCO Consultant, you get a single-point solution for all your registration and import license needs.
Post-Approval Compliance & Renewals
Once approval is obtained, maintaining compliance is equally important. CDSCO may require:
- Periodic renewal of licenses
- Reporting of adverse events
- Product recalls or labeling updates
Our CDSCO Consultant team assists in renewal submissions, amendments, and any post-market compliance needs to keep your business legally secure.