Introduction
India is one of the fastest-growing markets for medical devices. Manufacturers from France, Germany, Italy, the United Kingdom, Other European Countries, United States etc are expanding into India, but they need to follow the Indian medical device regulations to get approval prior to selling their devices into India.
The Central Drugs Standard Control Organization (CDSCO) regulates medical device approvals in India. Companies must adhere to medical device regulatory compliance in India to to get their approval in India prior to commercialisation. This guide explains the India medical device registration process and how Morulaa HealthTech can help European, UK, US manufacturers etc enter the Indian market in a streamlined manner.
Approval Process for CE Marked and US FDA-Approved Devices
If a medical device already has US FDA approval or a CE Mark, the approval process in India can be more streamlined. However, a key challenge that often surprises regulatory teams is the level of documentation required. Unlike many Southeast Asian markets, where a technical file with intended use, Instructions for Use (IFU), and core device information is sufficient, India requires a full set of technical documentation along with quality management system (QMS) documents. The good news is that in most cases:
- Local testing of the medical device in India is not required.
- Translation of IFUs into India’s 35 – 40 local languages is not mandatory.
However, the time-consuming part is preparing the extensive documentation required for submission.
1. Overview of Indian Medical Device Regulations
Who Regulates Medical Devices in India?
The CDSCO (Central Drugs Standard Control Organization) is India’s main regulatory authority. It ensures all imported medical devices meet safety and quality standards before being sold in India. In India Medical device regulations is managed by the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health. These devices are regulated by the Drugs and Cosmetics Act of 1940. Our expertise with CDSCO import license form MD14 and adherence to the Medical Device Rules India 2017 to ensure that your products meet regulatory standards. Manufacturers from France, Germany, Italy, the UK, and the US and all international markets should follow these laws to enter the Indian market.
2. Medical Device Classification in India
India follows a risk-based classification system similar to EU MDR and US FDA regulations.
Class | Risk Level | Examples |
Class A | Low Risk | Surgical gloves, Thermometers |
Class B | Low-Moderate Risk | Blood pressure monitors, Nebulizers |
Class C | Moderate-High Risk | Infusion pumps, Dialysis machines |
Class D | High Risk | Heart valves, Ventilators |
Before applying for India medical device registration, manufacturers from international markets such as France, Germany, Italy, the United Kingdom, Other European Countries, United States etc must identify their device classification.
3. Step-by-Step Process for Medical Device Registration in India
Step 1: Identify Your Device Classification
Use CDSCO guidelines to determine if your device falls under Class A, B, C, or D.
Step 2: Appoint an Authorized Indian Agent
International manufacturers must appoint an Indian Authorized Representative to handle regulatory processes. Morulaa HealthTech offers this service for smooth communication with the CDSCO.
Step 3: Submit an Application via SUGAM Portal
- All applications must be submitted through the SUGAM online portal. Some of the documents include Device Master File (DMF)
- Free Sale Certificate (FSC) (from the country of origin)
- ISO 13485 Certification
- Clinical Data and Performance Reports
A detailed checklist of the documents required can be found here
Step 4: Get Import License (Form MD-15)
Foreign manufacturers should obtain an Import License (Form MD-15) before selling medical devices in India.
Step 5: Ensure Proper Labelling and Packaging
All medical devices imported from France, Germany, Italy, the UK, Other European Countries, the US etc must follow India’s labelling requirements:
- Generic Name
- Maximum Retail Price (MRP)
- Net Quantity
- Month/Year of Import
- Import License Number
- Importer
- Imported For
Step 6: Post-Market Surveillance (PMS) Compliance
Once approved, manufacturers must follow post-market surveillance (PMS) rules, including reporting adverse events under the Materiovigilance Program of India (MvPI). Morulaa HealthTech assists in handling all registration, licensing, and post-market compliance.
4. New Updates in Indian Medical Device Regulations (2023-2024)
- Mandatory Registration for All Devices – Previously only 37 medical devices required registration in India. However, since 2020, all medical devices including wheelchairs, curtain and software now now require CDSCO approval.
- Stricter Post-Market Monitoring – More focus on tracking product safety and performance.
Manufacturers from France, Germany, Italy, the UK, Other European Countries, US etc and all other markets must stay updated to avoid legal issues and suspension of their license in India.
Why India is a Key Market for Medical Device Companies
- Huge Growth Potential: India’s medical device market is expected to reach $30 billion by 2030, making it one of the biggest opportunities for global manufacturers. The Government is supporting foreign manufacturers in several ways such as
- 100% Foreign Direct Investment (FDI) allowed in medical devices.
- Make in India and PLI (Production Linked Incentive) Schemes offer tax benefits.
- High Demand for Imported Devices: Hospitals in Mumbai, Delhi, Bangalore, Chennai, and other major cities prefer high-quality imported medical devices from France, Germany, Italy, the UK, Other European Countries, US etc. Morulaa HealthTech helps foreign manufacturers enter the Indian market smoothly by handling the entire regulatory process.
Streamline Your Regulatory Submission with Morulaa
Entering the Indian medical device market offers huge opportunities for companies from France, Germany, Italy, the United Kingdom, Other European Countries, United States, etc. However, manufacturers must comply with strict CDSCO regulations to sell their products legally. By working with Morulaa HealthTech, global companies can easily complete India medical device registration and launch their products in India without delays.