Get Your CDSCO Compliance Quote
Manufacture, import or sell in India with the licence in hand
A hospital tender, an importer or a distributor has asked for your CDSCO licence number. Manufacturing, importing or selling medical devices and drugs in India runs on licences granted under the Medical Devices Rules and the Drugs and Cosmetics Act, and the class of your product decides which authority grants them.
You need CDSCO Compliance if…
- !A government or hospital tender has asked for your manufacturing or import licence number before it will accept the bid.
- !You are appointing an Indian agent to import your device and need someone competent to hold the licence.
- !Your product has been reclassified into a higher risk class and the state licence no longer covers it.
- !A CDSCO or state inspection has raised observations against the Fifth Schedule quality system requirements.
- !You are launching a new device family in India and the classification is genuinely unclear.
- !The five-year retention fee on an existing licence has been missed and the licence status is now in doubt.
The licensing regime that decides whether a medical device or drug can legally be made, imported or sold in India. Risk class sets which authority licenses you, what evidence is needed and how the site is inspected.
CDSCO and the State Licensing Authorities grant the licences; no private body can. SIS audits the plant and quality system against the Rules, certifies the ISO 13485 system behind it.
Manufacturing and import licences under the Medical Devices Rules run in perpetuity, subject to a retention fee paid before every fifth year and continued conformity.
Indian device and drug manufacturers, overseas manufacturers appointing an Indian agent, importers, loan licensees and companies bidding for public health tenders.
Where this certification is demanded
CDSCO Compliance is applicable across 2 of the 25 industries SIS covers. The pages below set out the specific reason it comes up in each one.
What CDSCO Compliance Actually Requires
The backbone an implementer has to build, in the order it usually gets built.
Class A, B, C or D decided against the published classification lists and intended use, because it sets the authority, the forms, the fees and the inspection route.
State Licensing Authority for Class A and B, Central Licensing Authority for Class C and D, with separate routes for import, loan licence and test licence.
A Plant Master File describing the site and a Device Master File covering design, materials, sterilisation and shelf life, both written to the format the Rules set out.
A quality management system meeting the Fifth Schedule, in practice built on ISO 13485, with design control, sterilisation validation and complaint handling that an auditor can follow.
Performance and safety test reports from a government-approved or NABL-accredited laboratory, plus essential principles compliance, stability or shelf-life data and, where required, clinical evidence.
Labels carrying the required particulars, the licence number and importer details, plus adverse event reporting, recall capability and notification of changes to a licensed product.
How CDSCO Compliance Licensing Works
No black box. A defined, time-bound route from first call to licence granted by the authority.
Classification & Licence Route
We settle the risk class, whether you are manufacturing, importing or holding a loan licence, which authority applies, and how the product family should be grouped in one application.
3–5 daysDossier & Plant Readiness Audit
The Device Master File is where applications come apart, written like a brochure when the Rules ask for a specified structure. We audit it and the plant before anything is filed.
3–8 weeksApplication, Inspection & Queries
The application goes on the online portal. Class A and B sites are audited by a notified body registered with CDSCO; Class C and D are inspected by central licensing officers.
Set by class and authorityLicence Granted, Then Maintained
The authority grants Form MD-5, MD-9 or MD-15. SIS does not, and cannot. What puts a live licence in doubt afterwards is the retention fee nobody diarised before the fifth year.
Perpetual; retention fee every 5 yearsIndustries That Need CDSCO Compliance
Commonly taken alongside
Not Sure Which Certification You Need?
Three questions. The selector reads the same industry-to-standard mapping this whole site is built on, then shortlists what applies to you.
Which sector best describes your organisation?
Class A, or has it quietly become Class C?
Which authority licenses your product - the state or the centre? If that is not settled, the classification is not settled either, and the fees and inspection route follow from it.
Get My Free Quote →What CDSCO Compliance Changes for Your Business
Certification is not a certificate on the wall. It is a working system that pays for itself.
Tender eligibility protected
Government and hospital tenders verify licence status before award. A live licence in the right class is often the difference between a qualified bid and a rejected one.
Fewer regulatory queries
Most delay comes from query letters on classification, test reports and the master files. Fixing those before filing removes whole rounds of correspondence.
One quality system, two purposes
The Fifth Schedule system and ISO 13485 overlap heavily. Building it once and certifying it serves both the Indian licence and your export markets.
An import route that works
An Indian agent, the right licence and correct labelling let shipments clear rather than sit at the port waiting for a document nobody prepared.
Changes handled properly
Site moves, new variants and process changes need notification. Handling them under a controlled procedure keeps the licence intact instead of quietly invalid.
Post-market obligations covered
Adverse event reporting and recall capability are licence conditions, not optional extras. Having them working stops an inspection turning into a suspension.
Knowledge Base - Downloads
Practical documents prepared by our auditors. Fill the short form once and every download on the page unlocks.
CDSCO device licence document checklist
Every document a Class A to D application needs, in the order the authority reviews them, with the usual query triggers marked.
Plant Master File and Device Master File outline
Section headings and expected content for both master files, written to the structure the Medical Devices Rules actually require.
Classifying a device under MDR 2017
How Class A, B, C and D are decided, where the published lists help, and what to do when a product is not listed.
Import licensing through an Indian authorised agent
How the agent relationship works, what the overseas manufacturer must supply, and where responsibility sits once product is in the country.
Frequently Asked Questions
Straight answers to what buyers ask before they commit to CDSCO Compliance.
Is CDSCO compliance a certification?
Which authority licenses our device?
How long does a CDSCO licence last?
Do we need ISO 13485 for a CDSCO application?
We are an overseas manufacturer. Can we hold the licence ourselves?
How long does the whole process take?
Start your CDSCO licensing readiness audit
Filing early does not make a licence come faster; it makes query letters. The readiness audit is the cheaper way to find out what the authority will ask for.
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