A Complete Guide to Medical Device Registration in India

Comprehensive Guide to Medical Device Registration in India

Introduction

India’s healthcare industry is rapidly evolving, and with it comes the need for stringent medical device regulations. The Central Drug Standard Control Organization (CDSCO), under the Ministry of Health, oversees medical device registration in India. Governed by the Drugs and Cosmetics Act, 1940 and updated with the Medical Device Rules (MDR), 2017, the regulatory framework has adapted to include advanced healthcare technologies. This blog provides a complete guide to navigating the registration process for medical devices in India.

Step 1: Selecting the Right License Holder

To register a medical device in India, a local Indian company must act as the license holder. This could be:

• A local subsidiary
• An independent agent
• A trusted distributor

The license holder should possess:

• A Wholesale Drug License or MD-42 Registration Certificate
• A SUGAM portal account for submitting documents to the CDSCO
• Import Export (IE) Code, GST number, and other statutory licenses

Opting for an independent agent often provides a secure and economical path, ensuring compliance without limiting market flexibility.

Step 2: Classification of Medical Devices

Medical devices in India are classified based on risk levels:

• Class A: Low-risk (e.g., thermometers)
• Class B: Moderate-risk (e.g., surgical masks)
• Class C: High-risk (e.g., orthopedic implants)
• Class D: Highest-risk (e.g., heart valves)

Key Points on Classification:

• Class A (non-sterile, non-measuring devices): Self-notified, requiring minimal review.
• Other Classes (A, B, C, D): Require CDSCO review and approval.

The classification aligns with EU MDR standards, helping manufacturers determine appropriate categories.

Step 3: Predicate Devices and Global Approvals

Medical devices with a substantially equivalent predicate—devices with similar materials, design, and use already approved in India—enjoy a simpler approval process. Devices with approvals from GHTF countries (Australia, Canada, EU, Japan, UK, USA) also benefit from an expedited pathway.

Devices without predicates or global approvals may face additional scrutiny, including a review by the Special Expert Committee (SEC) or the Medical Device Advisory Committee (MDAC).

Step 4: Document Submission and Costs

To begin registration, manufacturers must submit:

1. MD-14 Application Form: Detailing the device's generic name, intended use, material, model numbers, and accessories.
2. Supporting Documents: Including ISO 13485 certificates, Free Sale Certificates, Declaration of Conformity, and more.
3. Fees: Based on device classification.

Key Portals and Documents:

• Use the SUGAM portal for submission.
• Provide Plant Master File (PMF) and Device Master File (DMF).

The submission is reviewed, and queries are raised if additional details are required. Once approved, an MD-15 Import License is issued.

Step 5: Timelines and Renewals

The approval process generally takes 6–9 months, depending on the completeness of the dossier. Devices requiring additional reviews or without predicates may take longer.

License Validity:

• Licenses do not expire but require retention fees every five years.
• Manufacturers must update the CDSCO with any post-approval changes to maintain compliance.

Challenges and Best Practices

1. Complex Documentation: Ensure all submissions are accurate and complete to avoid delays.
2. Regulatory Updates: Stay informed about changes like the inclusion of artificial intelligence in medical device regulations.
3. Distributor Management: Choose reliable distributors to streamline the market entry process.

Why Compliance Matters

India’s healthcare market is poised for significant growth, making regulatory compliance crucial for manufacturers looking to establish their presence. Proper registration ensures:

• Patient safety
• Legal market entry
• Long-term trust with healthcare providers

How Medvision Venture Can Help

At Medvision Venture, we simplify the complexities of medical device registration. From selecting the right license holder to preparing and submitting documents, our experts guide you every step of the way.

Contact us today to ensure a smooth, efficient, and compliant registration process for your medical devices in India.