We prepare, file and follow through your CDSCO registration on the SUGAM portal — medical devices, drugs and cosmetics — so your file moves and your product reaches the Indian market on schedule.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulator for drugs, cosmetics and medical devices, functioning under the Directorate General of Health Services. No notified drug, cosmetic or medical device can be legally manufactured, imported or sold in India without the registration, licence or approval CDSCO issues.
For manufacturers and importers, that means every product, every manufacturing site and every label has to clear a documentation and technical review process before it reaches the shelf. We manage that process — from classifying your product correctly to closing out queries the licensing authority raises along the way.
Each licence type follows its own form, timeline and documentation standard. We match your product to the right pathway before we file.
Class A, B, C and D device registration and licensing under the Medical Device Rules, 2017.
Import registration and licensing for drugs and medical devices entering India.
State and central manufacturing licences for drugs and devices produced in India.
Import and manufacturing registration for cosmetics under the Cosmetics Rules, 2020.
Drug wholesale and loan licensing for distribution and contract manufacturing.
End-to-end application filing and status tracking on CDSCO's SUGAM portal.
We review your product, intended use and manufacturing details to confirm the correct licence category and device class before anything is filed.
We draft and compile the technical file, undertakings, test reports and site documentation required for your specific application.
Your application is filed on the SUGAM portal with the correct form, fee category and supporting attachments.
We track your file, respond to queries raised by the reviewing officer and resubmit documentation as required.
Once approved, we hand over the registration certificate or licence along with a summary of renewal timelines.
The exact list depends on your licence type — this is the core set we start with for most applications.
We work inside SUGAM regularly and know how filings are actually reviewed, not just how the form reads.
Technical files, undertakings and site documents are drafted and checked before submission, not outsourced.
You get a single point of contact who tracks your file and responds to queries without delay.
We confirm classification and licence category upfront so you don't file under the wrong pathway.
CDSCO certification is the regulatory approval issued by India's Central Drugs Standard Control Organisation, permitting the manufacture, import or sale of drugs, cosmetics and medical devices in the Indian market.
Manufacturers, importers and marketers of drugs, cosmetics and medical devices sold in India need CDSCO registration or licensing before their products can legally enter the market.
Timelines vary by licence type and device class, typically ranging from 3 to 9 months depending on documentation readiness and query cycles with the licensing authority.
SUGAM is CDSCO's online portal used to file applications for drug, cosmetic and medical device licences, track status and respond to queries raised by the regulator.
Medical devices are classified by risk under the Medical Device Rules, 2017: Class A (low risk) and B (low-moderate) are state-licensed, while Class C (moderate-high) and D (high risk) require central licensing through CDSCO.
Yes. Import of notified medical devices into India requires a valid import licence from CDSCO along with a registration certificate for the manufacturing site.
A Free Sale Certificate confirms a product is legally sold in its country of origin and is often required to support export or import registration applications.
Government fees depend on licence type, device class and number of products or sites, and are separate from consultancy fees. We provide an itemised estimate after reviewing your product profile.
Most CDSCO licences remain valid until suspended or cancelled, though certain registration certificates carry defined validity periods that require renewal.
Yes. Foreign manufacturers must appoint an Indian Authorised Agent to file and manage the CDSCO registration or import licence application on their behalf.