Get CDSCO registration support from Legal Startup for medical devices, drugs and cosmetics. A dedicated regulatory expert identifies the right approval for your product, prepares the documents, files the application and handles queries from the regulator.
Free call & custom quote · Professional fee + government fee
CDSCO registration in India means getting the required licence, registration certificate or import approval from the Central Drugs Standard Control Organisation (or the State Licensing Authority, for some categories) before you manufacture, import or sell regulated drugs, medical devices or cosmetics. It is not a single certificate: the exact approval depends on your product and whether you manufacture or import it.
Last updated: October 2026. Rules, forms and fees can change, so we confirm the current position before filing.
CDSCO is India's national regulator for drugs, medical devices and cosmetics, functioning under the Directorate General of Health Services, Ministry of Health and Family Welfare. It sets standards for quality and safety and, together with the State Licensing Authorities, issues the licences that businesses need to operate legally.
In practice, "CDSCO registration" covers several different approvals. A medical device maker may need a manufacturing licence, an importer may need an import registration or licence, and a cosmetic importer needs an import registration certificate under the Cosmetics Rules, 2020. Some licences, such as lower-risk device manufacturing, are issued by the State Licensing Authority and others by CDSCO directly.
Choosing the right route at the start saves months of rework, because the documents, quality system and technical files differ for each category. For official notices, forms and the online portal, visit cdsco.gov.in, the website of the Central Drugs Standard Control Organisation. If you are launching a healthcare brand, see our trademark registration online service.
What every manufacturer and importer should know before applying.
The right approval depends on your product and your role.
For Indian manufacturers of regulated medical devices.
For importers and authorised agents of foreign manufacturers.
For bringing finished drugs or APIs into India.
For importers of cosmetic products.
For Indian manufacturers, usually through the State authority.
Several products, sites or licences to be managed together.
Not sure which approval applies to your product? Send us the product details and our experts will review it free of charge.
Why manufacturers and importers get their approvals in place before launch.
Operate within the Drugs and Cosmetics Act and avoid enforcement action.
Hospitals, distributors and tenders generally expect valid approvals.
Regulatory approval shows that quality and safety checks were followed.
Customs and port clearance depend on the required import approvals.
A clean regulatory record supports funding, partnerships and exports.
Filing and follow-up are handled online without office visits.
From product review to approval, here is how CDSCO registration works.
Timelines depend on the product, risk class and regulator workload. Not to scale.
We confirm whether your product is a drug, device or cosmetic, its risk class, and whether you need a manufacturing or import approval.
We review your premises, quality system, labels and technical information against the requirements and flag gaps.
Authorisation letters, Power of Attorney, technical files and declarations are prepared in the required format.
The application is filed on the relevant portal and the government fee is paid.
We reply to the regulator's queries and help you prepare if an inspection or audit is called for.
Once granted, we explain the licence conditions, validity and renewal dates.
Keep these ready to avoid delays. The exact list depends on your product, and our expert will confirm it for your case.
The total cost depends on the product category, risk class, number of products or sites, and whether you are manufacturing or importing. It generally has three parts:
Set by the applicable rules and varies by product and class. The schedule can change, so we confirm the current fee before filing.
Our fee depends on the number of products and the complexity. Call free for a custom quote before you pay anything.
Testing, quality system set-up, translations and inspection preparation are charged separately.
We share a clear, itemised quote before you begin – no hidden charges. Get your free quote →
Choose the situation that matches your product, or call free for a custom quote.
You manufacture or import a medical device in India.
You import drugs, devices or cosmetics, or represent a foreign manufacturer.
Several products, sites or approvals that need ongoing management.
Our professional fee is quoted after a free call. Government fee is separate and depends on the product and class. Approval is decided by the regulator and cannot be guaranteed. Not sure which option fits? Ask for a free product review.
If your product is used on or in the human body, check whether it is regulated.
Makers of devices such as diagnostics, surgical items and implants.
Businesses bringing regulated products into India for sale.
Overseas companies entering the Indian market through an authorised agent.
Importers of cosmetic products that need registration certificates.
New ventures building devices, diagnostics or health products.
Companies importing drugs or active ingredients for the Indian market.
A quick view of the common routes. Ask us which one applies to your product.
| Route | Who applies | Product | Issued by | Key requirement |
|---|---|---|---|---|
| Device manufacturing licence | Indian manufacturer | Medical devices | State authority or CDSCO, by class | Quality system and premises |
| Device import licence | Importer or authorised agent | Medical devices | CDSCO | Manufacturer documents and Indian agent |
| Drug import registration | Importer for foreign manufacturer | Drugs and APIs | CDSCO | Dossier and authorised agent |
| Cosmetics import registration | Importer | Cosmetics | CDSCO | Product and manufacturer details |
Most delays come from the wrong route or incomplete documents.
Approval is the start. Here is how to keep it in good standing.
Understand the scope, validity and conditions attached to your approval.
Keep labels, records and quality processes in line with the rules.
Inform the authority about changes in premises, products, manufacturer or ownership as required.
Note the validity and retention dates and set reminders well ahead.
Quick answers on CDSCO registration in India.
CDSCO registration refers to the approvals, licences or import registrations issued under the Central Drugs Standard Control Organisation for drugs, medical devices and cosmetics in India. The exact approval depends on the product, its risk class and whether you manufacture or import it.
CDSCO is India's national regulatory body for drugs, medical devices and cosmetics, working under the Directorate General of Health Services, Ministry of Health and Family Welfare. It operates under the Drugs and Cosmetics Act, 1940 and the rules made under it.
Yes. Under the Medical Devices Rules, 2017, manufacturers and importers of regulated medical devices need the applicable licence or registration, and the requirement depends on the device's risk class. Check your product's status before launch.
Medical devices are classified by risk into Class A (low), B (low-moderate), C (moderate-high) and D (high). The class decides the licensing authority, the documents needed and the review involved.
Identify the product category and risk class, prepare the technical and legal documents, create an account on the relevant CDSCO online portal, file the application with the prescribed fee, and reply to any query raised by the regulator.
Typically business registration papers, a Power of Attorney or authorisation, premises details, product and technical information, quality management system documents, test or free-sale certificates for imports, and the Indian agent details for foreign manufacturers. The list varies by product.
Foreign manufacturers generally need an authorised agent in India to apply for import registration or licence on their behalf. The agent also holds the required local licence where applicable.
The time depends on the product category, risk class, completeness of documents and any queries raised by the regulator. Higher-risk products and incomplete files take longer, so we give a realistic estimate after reviewing your case.
The government fee depends on the product type, risk class and number of products or sites. Our professional fee is quoted after a free call, and we share an itemised quote before you pay.
Imported cosmetics need a registration certificate from CDSCO under the Cosmetics Rules, 2020. Cosmetics manufactured in India are generally licensed through the State Licensing Authority.
Selling or importing regulated products without the required approval can lead to action under the Drugs and Cosmetics Act, 1940, including seizure of stock, penalties and prosecution. Get the approval in place before launch.
Planning to manufacture or import a regulated product? Speak to our regulatory expert today – the product review and the quote are free.
Tell us what you need and our team will get back to you with the right guidance.
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