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Book Free Consultation →End-to-end CDSCO registration support for all classes of medical devices — from Class I self-certification to Class IV high-risk devices and in-vitro diagnostics. We handle everything.
Under Medical Devices Rules 2017, all devices are classified into four risk-based classes — each with distinct registration requirements and timelines.
Lowest risk devices that pose minimal potential for harm. Registration via self-certification on the Sugam portal. No CDSCO technical review required.
Moderate risk devices requiring Central Licence from CDSCO. Performance standards apply. Technical documentation and testing reports are mandatory.
High risk devices requiring full technical review by CDSCO. Comprehensive clinical data, biocompatibility testing, and performance evaluation required.
Highest risk devices in direct contact with the central nervous system or heart. Requires extensive clinical trials data, full CDSCO technical committee review.
Our structured 7-step process ensures maximum success rate and minimal back-and-forth with CDSCO authorities.
We begin with a detailed regulatory review of your device — determining its correct classification under MDR 2017, mapping required documents, and identifying gaps to address before submission. This prevents rejection and saves months of delay.
The documentation checklist varies by device class. Below is a comprehensive breakdown of what CDSCO requires at each tier.
CDSCO government fees depend on device class and applicant type (Indian vs foreign manufacturer). Timelines are statutory but can vary based on query resolution speed.
| Device Class | Risk Level | Indian Manufacturer Fee | Foreign Manufacturer Fee | Statutory Timeline | Key Requirement |
|---|---|---|---|---|---|
| Class I | Low Risk | ₹ 2,500 – ₹ 5,000 | USD 250 – 500 | 30–45 days | Self-certification on Sugam |
| Class II | Moderate Risk | ₹ 5,000 – ₹ 15,000 | USD 500 – 2,000 | 3–6 months | CDSCO Central Licence, ISO 13485 |
| Class III | High Risk | ₹ 15,000 – ₹ 50,000 | USD 2,000 – 6,000 | 9–15 months | Full technical review, clinical data |
| Class IV | Very High Risk | ₹ 50,000 – ₹ 1,00,000 | USD 6,000 – 15,000 | 12–18 months | Committee review, clinical trials |
| IVD Class B | Moderate Risk | ₹ 5,000 – ₹ 20,000 | USD 1,000 – 3,000 | 4–8 months | Performance evaluation, specificity data |
| IVD Class D | Very High Risk | ₹ 50,000+ | USD 8,000+ | 12–18 months | Full clinical validation, commutability |
IVD devices follow the same MDR 2017 framework but with distinct classification criteria (Class A–D) and performance evaluation requirements unique to diagnostics.
General laboratory instruments, specimen receptacles, culture media. Class A = self-declaration; Class B requires CDSCO licence with performance data.
Tests for serious communicable diseases, donor blood screening, tumour markers. Full performance evaluation, analytical sensitivity and specificity data mandatory.
Tests used for blood transfusion safety and organ transplant compatibility. Highest scrutiny — full clinical validation and commutability studies required.
For foreign IVD manufacturers, the MD-41 Import Registration is required before commercial sale in India. This is separate from domestic manufacturing licence.
Get IVD Registration Help →15+ years of dedicated CDSCO expertise means fewer queries, faster timelines, and a near-perfect approval rate.
Our regulatory experts include former CDSCO review officers who understand exactly what the authority looks for in every submission.
Ready-to-use CDSCO-compliant technical file templates for all device classes cut documentation time by up to 60%.
We regularly handle registrations for manufacturers from USA, Germany, Japan, South Korea and Taiwan — fluent in bridging global standards to Indian requirements.
All technical files, formulations and clinical data are protected under comprehensive NDAs. We never share client data with third parties.
"RegPath handled our Class III orthopaedic implant registration from start to finish. CDSCO approval in 11 months — faster than we expected for such a complex device."
Answers to the most common questions we receive from medical device manufacturers about CDSCO registration in India.
Book a free 30-minute consultation with our CDSCO experts. Get clarity on your device class, required documents, timeline and our fee — at no cost.