CDSCO Registration for Medical Devices
Ensure regulatory compliance with expert help from Operon Strategist
We support medical device manufacturers, importers, and exporters through every step of CDSCO registration in India. Whether you’re launching a new product or entering the Indian market, our team ensures your registration is fast, accurate, and compliant.
What is CDSCO Registration?
CDSCO (Central Drugs Standard Control Organization) is the national regulatory authority in India that oversees the safety, quality, and performance of medical devices. Any medical device—whether manufactured in India or imported—must be registered with CDSCO before being sold in the Indian market.
Registration is based on risk classification:
- Class A & B – Low to moderate risk
- Class C & D – Moderate to high risk
CDSCO registration is mandatory under the Medical Device Rules, 2017.
Get Expert Help with CDSCO Registration
Who Needs CDSCO Registration?
You need CDSCO approval if you are:
- An Indian manufacturer of Class A, B, C, or D devices
- A foreign manufacturer planning to sell in India
- An importer or distributor bringing devices into India
- A legal representative of a foreign medical device brand
We work with all these profiles to ensure a smooth and fast registration process.
Step-by-Step CDSCO Registration Process
Here’s how we help you register your medical device with CDSCO:
- Device Classification – We assess your product and determine the correct risk class.
- Appoint Indian Authorized Agent – For foreign companies, this is required to act as a local contact.
- Documentation Preparation – We help prepare and review all technical, administrative, and clinical documents.
- Online Application Submission – We file applications on the CDSCO portal using Form MD-14, MD-15, or others based on the case.
- Technical Review – CDSCO may raise queries; we handle responses and clarifications.
- Certificate Issuance – Once approved, you receive the official CDSCO registration certificate.
What are the Objectives of CDSCO Registration?
- Approval of new drugs and clinical trials.
- Import licensing.
- Manufacturing medical devices licensing.
- Licensing of blood banks, vaccines and some medical devices.
- Amendment to Drugs & Cosmetics Act and rules.
Classification of Medical Devices as per CDSCO:
MDR 2017 has categorized the devices as Class A, Class B, Class C and Class D. Below table will spread some light on classification of medical devices.
Type | Risk | Example |
Class-A | Low risk | Bandage, examination loves etc. |
Class B | Low-Medium Risk | B.P. monitoring device, thermometer |
Class C | Moderate to High Risk | Implants, catheter |
Class D | High Risk | Heart Valve. |
Medical Device Registration for Import:-
Medical Devices entering India must be in compliance with the Indian medical device regulation set forth by the CDSCO for Registration. The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, control over the quality of imported drugs, coordination of the activity of State Drug Control Organizations. Operon Strategist assists medical device distributors and medical device wholesalers in UK to procure CDSCO import license for medical devices.
Application Process to Grant Indian Import License:
An Import license is issued for import of medical device from UK to India. Both the foreign company and Indian company jointly needs to submit the documentation for medical device and manufacturing unit. Process in brief:
Appointment of authorized agent having license for sale or distribute in India, eligible to make an application to grant import license.
Submission of the documents along with the application.
After examining the documents along with the application on the basis of the inspection report, if the inspection has been done by the Central Licensing Authority can be satisfied, grant license in Form MD-15/26
To export medical devices FDA issues export certification and charges fee for that certification. The export certification is a document which contain the information about products regulatory and marketing status in UK.
Operon Strategist's Role in CDSCO Registration?
With over 15 years in the regulatory consulting space, we bring hands-on experience in helping global and Indian companies register their devices successfully.
What you get:
- CDSCO registration support for all device classes
- End-to-end project management from classification to approval
- Preparation of technical files and documentation
- Query handling with CDSCO authorities
- Ongoing regulatory guidance after registration
Ready to Get Your Medical Device Registered with CDSCO?
Operon Strategist offers expert Indian CDSCO registration consultancy worldwide! 🌍✅
FAQs
For the import of cosmetics in India, the imported cosmetics products are required to be registered with Central Drugs Standard Control Organization (CDSCO).Cosmetic products and color additions do not need FDA approval before they go in the market. Although they should not be contaminated or misbranded. It means that they should be safe for the customers under labeled customary conditions to use, and they must be properly labeled. In the case of color additions and those ingredients which are banned or restricted by FDA regulations, a cosmetic firm can use any ingredient as long as it does not cause the product to be contaminated.
IEC Import Export Code is the first requirement you before you start an import/export code in India. An IEC is important for the import and export of goods. The IEC is issued by the Directorate General of Foreign Trade (DGFT) Ministries of Commerce and Government of India. For releasing any medical device the manufacturer has to attach to various rules set by the national regulatory bodies of India. The main regulatory body of India is Central Drugs Standard Control Organization (CDSCO). It is under Directorate General of Health Services, Ministry of health and family welfare. Under the drugs and cosmetics act CDSCO is responsible for the approval of drugs, conduct of clinical trials, laying down the standard of drugs, control over the quality of imported drugs, in the country. Further CDSCO along with state regulators is jointly responsible for granting licenses of certain specialized categories of critical drugs such as blood and blood products I.V. Fluids, Vaccine and sera.
Ans-Yes. Under the provision of Drugs and Cosmetic act 1940, registration certificate and import license are required to import in India. For the introduction of medical device in the Indian market, the Manufacturers has to obey various norms set by national regulatory bodies of Saudi Arabia. The main regulatory body for medical device in India is Central Drugs Standard Control Organization (CDSCO). The Application for all classes of medical devices are submitted to Central Licensing Authority, where the (DCGI) Drug Controller General of India takes the responsibility for approval of Manufacturing, Registration, Import and Sale of Medical Devices in Saudi Arabia. When the Medical Device released to be imported it has some issued steps to be followed. The importers may also get the respective sale license from the State Licensing Authorities (SLA).