Medical Device Registration
Indias medical device market is growing fast due to rising healthcare needs and new technologies. To keep patients safe, every medical device must be approved before it can be made or sold in the country.
Get Free Consultation
What is Medical Device Registration?
Indias medical device market is growing fast due to rising healthcare needs and new technologies. To keep patients safe, every medical device must be approved before it can be made or sold in the country.
The Central Drugs Standard Control Organization (CDSCO) is the government body that handles this process. Their job is to make sure that all medical devices meet safety and quality standards.
Medical device registration means getting official permission from the CDSCO to manufacture, import, or sell a device in India. This approval proves the device is safe and works as intended. Without it, making or selling medical devices in India is illegal.
Registering your device is not just a formality; it is a legal requirement. It helps protect patients, builds trust with users, and allows companies to avoid fines and operate legally in the Indian market.
Registration is required because:
In 2020, the government updated the rules to cover all medical devices as "Drugs" under the Medical Devices (Amendment) Rules, 2020. Before this, only 37 types of devices were regulated.
Eligibility Criteria
Authorized Agents in India: A legally appointed Indian representative who files the application, communicates with CDSCO, and ensures regulatory compliance. The agent must possess a valid wholesale license.
Indian Subsidiaries: If a foreign manufacturer has a registered subsidiary in India, the subsidiary can apply on behalf of the parent company. It acts as a local legal entity for registration and compliance.
Documents Required
Registration Process
Step 1: Classify Your Device and Group Products
First, find out your devices risk class. Devices are divided into four classes:
Step 2: Quality Management System (QMS) and ISO 13485 Compliance
You must have a Quality Management System (QMS). This system helps you make devices consistently and safely. Most manufacturers follow ISO 13485, an international quality standard for medical devices (mandated for Class B, C, D, and even recommended for A).
Step 3: Plant Master File & Device Master File)
Next, prepare your application with these key documents:
Step 4: Apply to the Right Authority: State (SLA) vs. Central (CLA)
Make sure you send your application to the correct authority.
Step 5: Visit the SUGAM Portal for Your Application (Forms MD-3, MD-7)
Submit your application online on the SUGAM portal. Use:
Step 6: The Audit and Inspection
After you apply, CDSCO or the State Authority will inspect your manufacturing site. They check if you follow good manufacturing practices and quality standards.
Step 7: Receive Your Manufacturing License (Forms MD-5, MD-9)
If everything is okay, you will get your manufacturing license:
Fees & Charges
| Fee Component | Amount |
|---|---|
| Class A devices | The registration fee is around ₹5,000 to ₹10,000. |
| Class B devices | Fees range from ₹10,000 to ₹20,000. |
| Class C devices | Fees can be ₹25,000 to ₹50,000. |
| Class D devices | Fees may go up to ₹1,00,000 or more. |
| Class A and B devices | Around ₹10,000 to ₹25,000. |
| Class C and D devices | ₹50,000 to ₹1,00,000 or more. |
| Audits and inspections | CDSCO or state authorities may charge fees for inspecting your manufacturing site. |
| Product testing | Some devices require third-party lab testing, which adds to the cost. |
Key Advantages
Legal Market Access and Compliance
Legal Market Access and Compliance
Enhanced Credibility and Trust
Enhanced Credibility and Trust
Unlocking Commercial Opportunities
Unlocking Commercial Opportunities
Ensuring Public Health and Patient Safety
Ensuring Public Health and Patient Safety
Streamlined Pathway for Global Players
Streamlined Pathway for Global Players
Frequently Asked Questions
Why Choose Us?
Expert Professionals Team
Qualified Chartered Accountants and Company Secretaries handle your filing.
Fast Processing
Quick turnaround with dedicated support at every step.
Transparent Pricing
No hidden charges. Know exactly what you pay for.
100% Data Security
Your documents and data are encrypted and confidential.
Trusted by Thousands
Thousands of businesses registered successfully.
24/7 Support
Dedicated relationship manager and customer support.