CDSCO Import License for Medical Devices In India

Introduction

All medical devices imported into India must adhere to the regulations outlined by the CDSCO (Central Drugs Standard Control Organization). CDSCO oversees the approval and regulation of medical devices and clinical trials within the country, establishing standards for drugs and ensuring control over the quality of imported medical devices. Additionally, CDSCO coordinates with State Drug Control Organizations to streamline regulatory activities.

Under the latest CDSCO guidelines, importers of Class A, B, C, and D medical devices risk suspension or cancellation of imports if they fail to meet CDSCO's mandatory import license deadlines. CDSCO has established a comprehensive procedure for granting licenses to import medical devices into India. This procedure applies to all importers and distributors bringing medical devices from overseas into India. Additionally, all medical devices must undergo classification according to CDSCO rules. Previously, manufacturers could sell medical devices in India without adhering to specific regulations, but since 2006, imported medical devices must comply with stringent import guidelines set by CDSCO.

CDSCO Import License Registration for Medical Devices

Pre-requisites for registration process of CDSCO for Medical Devices:

Generic Name / Brand Name
Intended Use
Material of construction
Mode of application
Analysis of device specifications and Risk-based classification of medical devices

Who Can Apply for CDSCO Registration in India?

Domestic Manufacturers of Medical Devices/IVDs
Importer of Medical Devices/IVDs/Cosmetics
Foreign Manufacturer of Medical Devices/IVDs/Cosmetics
Authorised Agent of Medical Devices/IVDs/Cosmetics
Indian Subsidiary of Medical Devices/IVDs/Cosmetics

Types of CDSCO Registration in India

Medical Devices Registration +

Businesses intending to manufacture medical devices in India must obtain Medical Device Registration from the Central Drugs Standard Control Organisation (CDSCO). This registration is issued by either the CLA or SLA, depending on the risk classification of the medical devices. Medical devices in India are categorized into four classes based on their associated risks:
- Class A includes devices with low risk, such as thermometers and sphygmomanometers.
- Class B comprises devices that pose low to medium risk, such as needles and suction cannulae.
- Class C includes devices with medium to high risk, such as ventilators and joint implants.
- Class D covers devices with high risk, such as pacemakers and heart valves.

Medical Devices Import License +

According to the Medical Devices Rules of 2017, obtaining a Medical Device Import License is mandatory for importing any notified medical devices. Businesses seeking to import medical devices must appoint an Authorized Agent in India and provide requisite approval certifications like CE certification, FDA Approval, EN certification, ISO certification, etc.

In-Vitro Diagnostic Device Manufacturing License+

Manufacturers intending to produce in-vitro diagnostic medical devices in India must first secure an IVD manufacturing license from CDSCO. In-vitro devices encompass kits, reagents, instruments, and systems utilized for diagnosing diseases or health conditions, including those used to assess a person's health for curing, treating, or preventing such diseases or their consequences. IVDs typically involve the collection, preparation, and examination of specimens from the human body.

In-Vitro Diagnostic Device Import License+

For businesses engaged in importing IVD medical devices into India, obtaining an IVD import license from CDSCO is mandatory. The application process for importing IVD devices can be completed online through the CDSCO Sugam portal, applicable to devices classified as Class A, B, C, and D. The license is issued by the CLA subsequent to evaluating the application and supporting documents, which include GMP certification, CE certification, ISO certification, PMS report, and details of the authorized agent.

Cosmetic Import License+

To import cosmetics from countries like China, Korea, the USA, the UK, etc., a business must obtain a cosmetics import license from CDSCO. Cosmetics encompass substances applied externally to alter, cleanse, or enhance appearance, including any articles used as part of cosmetic products.