CDSCO Registration
Medical device manufacturers and importers in India must comply with strict regulatory guidelines to ensure the safety, quality, and effectiveness of their products. The Central Drugs Standard Control Organisation (CDSCO) is India’s national regulatory authority responsible for approving and monitoring medical devices, pharmaceuticals, and cosmetics.
For any medical device company, CDSCO registration is mandatory to legally manufacture, import, distribute, or sell devices in the Indian market. Om Garuda Group, as a trusted compliance partner, provides expert support in CDSCO medical device certification, ensuring your business stays compliant with the Drugs and Cosmetics Act & Medical Device Rules.
What is CDSCO Registration Online?
CDSCO registration online is the official approval process that allows medical device companies—both domestic manufacturers and foreign suppliers—to operate in India. It confirms that the product meets Indian safety and performance standards.
Manufacturers must submit technical documents, product labels, clinical evidence (for higher-risk devices), and other details through the SUGAM portal. With Om Garuda Group, the entire process becomes clear, time-efficient, and error-free.
Importance of CDSCO Medical Device Certification
CDSCO certification is not just a legal requirement but also a mark of product reliability and safety. It builds trust with hospitals, healthcare providers, and end-users.
Key Benefits of CDSCO Certification:
- Legal right to market Class A, B, C & D devices
- Proof of safety and effectiveness for patient health
- Acceptance by hospitals and healthcare providers
- Compliance with the Drugs & Cosmetics Act
- Stronger market reputation and customer confidence
Who Needs CDSCO Registration Online?
CDSCO certification is mandatory for:
- Domestic medical device manufacturers
- Overseas manufacturers and authorized Indian agents
- Importers and distributors of regulated devices
- Repackers and relabelers of imported products
Types of Medical Devices Covered
CDSCO medical device certification applies to a wide range of categories, including:
- Surgical instruments & implants
- Diagnostic equipment
- Dental tools & devices
- Orthopedic implants & devices
- Disposable medical supplies
- Electronic health monitoring systems
Documents Required for CDSCO Registration
Om Garuda Group ensures every document is accurate before submission. Required documents include:
- Manufacturing or Import License
- Free Sale Certificate (FSC) from country of origin
- ISO 13485 Certificate
- Product labels & user manuals
- Clinical evaluation report (for higher-risk devices)
- Power of Attorney (if using an Indian agent)
Step-by-Step CDSCO Registration Process
- Product Classification – Identify correct device class (A, B, C, D).
- Document Preparation – Compile technical dossier and supporting documents.
- Online Application – File application on the SUGAM portal with required fees.
- CDSCO Review – Respond to queries, inspections, and clarifications.
- Approval Issued – Receive license for manufacturing or importing.
- Post-Approval Compliance – Renewals, reporting, and modifications as required.
Fees & Timelines
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Class A & B devices: 4–8 weeks
-
Class C & D devices: 8–20 weeks (may include site inspections)
Fees vary depending on device class and license type. Om Garuda Group provides a clear cost estimate before submission.
Post-Certification Compliance & Renewals
Once certified, companies must:
- Renew licenses within the validity period
- Submit periodic safety reports
- Report adverse events
- Update CDSCO on changes in device specifications
Om Garuda Group offers full post-approval support including renewals, reporting compliance, and modification management.
Benefits of Partnering with Om Garuda Group
- Accurate documentation & error-free applications
- Dedicated compliance managers to handle CDSCO queries
- Guidance on renewals & post-approval compliance
- 100% online support system with real-time updates
- Transparent pricing with no hidden charges
- Support in English & Hindi for easy communication
Common Challenges in CDSCO Registration
Without expert guidance, companies often face:
- Incorrect product classification
- Incomplete dossiers or missing documents
- Lack of clinical/test reports
- Delays due to compliance errors
Om Garuda Group’s expertise ensures you avoid these pitfalls and achieve faster approvals.
Why Choose Om Garuda Group?
- Experienced regulatory professionals with updated knowledge of CDSCO guidelines
- Proven track record of approvals across all device classes
- Transparent pricing & honest timelines
- Personalized one-on-one compliance support
- Long-term partnership with ongoing compliance assistance
Conclusion
CDSCO registration is not just a formality, but a crucial step to secure your medical device’s entry into the Indian market. With proper technical documents and expert guidance, approvals can be obtained smoothly.
Om Garuda Group ensures a hassle-free, professional, and compliant registration process, helping you build trust, meet regulations, and expand confidently in India’s growing healthcare sector.
Contact Om Garuda Group today to start your CDSCO registration online.