CDSCO registration and medical device licences in India — import, manufacture, sell.
Every medical device sold in India, from gloves and syringes to implants, ventilators and diagnostic kits, needs the right licence under the Medical Devices Rules, 2017. Imported cosmetics and drugs need CDSCO registration too. We classify your product, build the dossier, file on the CDSCO portals and answer every query until the licence is granted.
What CDSCO regulates, and who needs a licence
Medical Devices & IVDs
All medical devices and in vitro diagnostics, Classes A to D, are regulated under the Medical Devices Rules, 2017. Import needs a CDSCO licence; manufacture is licensed by the state or CDSCO depending on class.
Importers, Makers & Sellers
Importers need Form MD-15, manufacturers Form MD-5 or MD-9, and distributors a Form MD-42 registration or wholesale licence to stock and sell devices.
Class A Exemption
Class A devices that are non-sterile and non-measuring don’t need a manufacturing or import licence, but must be registered online, free, and labelled to MDR 2017.
CDSCO registration: the key facts
| Regulator | Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare; State Licensing Authorities for Class A and B manufacturing and device sales |
| Law | Drugs and Cosmetics Act, 1940; Medical Devices Rules, 2017; Cosmetics Rules, 2020; Drugs Rules, 1945 |
| Import licence | Form MD-14 application, MD-15 licence; $1,000 to $3,000 per site plus $10 to $1,500 per device by class; nine-month rule timeline |
| Manufacturing | Class A and B: Form MD-5 from the State Licensing Authority after notified body audit; Class C and D: Form MD-9 from CDSCO after inspection |
| Sale | Form MD-42 registration from the State Licensing Authority, issued within ten days if satisfactory |
| Exemption | Class A non-sterile, non-measuring devices: online registration only, no fee |
| Validity | Perpetual, with a retention fee every five years; test licences valid three years |
| Portals | cdscomdonline.gov.in for medical devices; SUGAM (cdscoonline.gov.in) for drugs and cosmetics |
| Consultant | Bizpro Compliance Services, New Delhi, handles CDSCO medical device, cosmetics and drug import registrations across India: +91 920 500 6364, contact@bizprocompliance.com |
Every CDSCO approval we handle, with official fees
Medical device import, manufacturing and sale licences under MDR 2017, plus clinical, export, cosmetics and drug import approvals. Search by form number, class or product type.
Showing all 19 CDSCO approvals
| No. | Approval | Government Fee | Authority | |
|---|---|---|---|---|
| 1 | Import licence, Class A medical deviceForm MD-14 → MD-15 | $1,000 per site + $50 per device | CDSCO (CLA) | |
| 2 | Import licence, Class B medical deviceForm MD-14 → MD-15 | $2,000 per site + $1,000 per device | CDSCO (CLA) | |
| 3 | Import licence, Class C or D medical deviceForm MD-14 → MD-15 | $3,000 per site + $1,500 per device | CDSCO (CLA) | |
| 4 | Import licence, Class A or B IVDForm MD-14 → MD-15 | $1,000 per site + $10 per device | CDSCO (CLA) | |
| 5 | Import licence, Class C or D IVDForm MD-14 → MD-15 | $3,000 per site + $500 per device | CDSCO (CLA) | |
| 6 | Test licence to import devices for testing, evaluation, demo or trainingForm MD-16 → MD-17 | $100 per device | CDSCO (CLA) | |
| 7 | Manufacturing licence, Class A or B deviceForm MD-3 → MD-5 | ₹5,000 per site + ₹500 per device | State Licensing Authority | |
| 8 | Loan licence, Class A or B deviceForm MD-4 → MD-6 | As per Second Schedule | State Licensing Authority | |
| 9 | Manufacturing licence, Class C or D deviceForm MD-7 → MD-9 | ₹50,000 per site + ₹1,000 per device | CDSCO (CLA) | |
| 10 | Loan licence, Class C or D deviceForm MD-8 → MD-10 | As per Second Schedule | CDSCO (CLA) | |
| 11 | Test licence to manufacture for testing, evaluation, demo or trainingForm MD-12 → MD-13 | ₹500 per device | CDSCO (CLA) | |
| 12 | Class A (non-sterile, non-measuring) device registrationOnline registration | No fee | CDSCO portal | |
| 13 | Registration to sell, stock or distribute medical devicesForm MD-41 → MD-42 | As per Second Schedule | State Licensing Authority | |
| 14 | Clinical investigation permission (pilot or pivotal)Form MD-22 → MD-23 | ₹1,00,000 | CDSCO (CLA) | |
| 15 | Permission for a device with no predicateRule 63 | ₹50,000 | CDSCO (CLA) | |
| 16 | Export certificates (free sale, market standing)Rule 91 | ₹1,000 per device | Licensing Authority | |
| 17 | Cosmetics import registrationForm COS-1 → COS-2 | $1,000 per category + $50 per variant + $500 per site | CDSCO via SUGAM | |
| 18 | Drug import registration certificateForm 40 → Form 41 | As per Drugs Rules, 1945 | CDSCO via SUGAM | |
| 19 | Drug import licenceForm 8 → Form 10 | As per Drugs Rules, 1945 | CDSCO via SUGAM |
“” isn’t in this list
Try a form number or device class, or tell us your product and we’ll confirm which CDSCO approval applies.
Tell us what the product is and we’ll confirm which approvals it needs, free.
Sources: Second Schedule of the Medical Devices Rules, 2017 (CDSCO fee schedule), the CDSCO medical devices portal FAQ and the Cosmetics Rules, 2020, checked on 1 November 2026. Fees exclude testing and notified body charges.
Get your CDSCO quote and timeline
Tell us the device and whether you import, make or sell it. A specialist confirms its class, the licences needed, total cost and timeline, in writing.
- Reply within one business dayFrom a named consultant, not an automated sales sequence.
- Fixed written quoteGovernment fees, lab charges and our fee listed separately before you commit.
- Class, dossier and queriesWe confirm the risk class, build the dossier and answer CDSCO until grant.
What a CDSCO import licence costs
Government fee per overseas site plus per distinct device. Manufacturing licences are charged in INR.
Request received
Thanks. A BIS specialist will reply within one business day with your standard, test plan, cost and timeline.
Send it with one tap instead
The form couldn’t send just now. Your details are ready in a message, so you only need to press send.
Medical device classes A to D, and what each needs
Under MDR 2017 every device is classed by risk. The class decides who licenses it, who audits the factory and how much evidence you need.
| Class | Risk | Typical Examples | Manufacturing Licence | Import Licence |
|---|---|---|---|---|
| Class A | Low | Non-sterile dressings, simple manual instruments | State Licensing Authority; non-sterile, non-measuring devices only need online registration | CDSCO, Form MD-15; non-sterile, non-measuring exempt |
| Class B | Low to moderate | Hypodermic needles, suction equipment, digital thermometers | State Licensing Authority, after a CDSCO-registered notified body audit | CDSCO, Form MD-15 |
| Class C | Moderate to high | Ventilators, orthopaedic bone plates and screws | CDSCO (Central Licensing Authority), after inspection | CDSCO, Form MD-15 |
| Class D | High | Heart valves, implantable pacemakers, HIV and hepatitis diagnostic kits | CDSCO (Central Licensing Authority), after inspection | CDSCO, Form MD-15 |
Examples are typical, not definitive. CDSCO publishes device-wise risk classification lists, and where India’s class differs from IMDRF countries, the higher class may be applied. We confirm your device’s class before filing.
How overseas manufacturers get an Indian import licence
Every imported medical device, Class A to D, needs an import licence in Form MD-15 from CDSCO, except Class A non-sterile, non-measuring devices, which only need online registration. The application is filed in Form MD-14 by the importer in India.
The importer must hold a manufacturing licence, a wholesale licence, or a Form MD-42 registration to sell and distribute devices. An overseas manufacturer appoints this firm as its authorised agent through a power of attorney. A change in the licensee’s constitution, in the overseas manufacturer that signed the power of attorney, or in the manufacturing site’s location requires a fresh licence.
CDSCO expects a free sale certificate from the USA, UK, EU, Canada, Japan or Australia. Without one, Class A and B devices can rely on published safety and performance data or clinical data from the country of origin, while Class C and D devices need a clinical investigation in India. CDSCO may inspect the overseas factory, at a fee of $6,000, and the rules allow nine months for the grant.
Import Licence Support
We prepare the full Fourth Schedule dossier and manage CDSCO queries until your MD-15 is granted.
- Device and plant master files
- Power of attorney and agent set-up
- India-specific labelling and stickering
- Retention fees tracked every five years
Your CDSCO import licence in five tracked stages
The rules allow CDSCO up to nine months to grant an import licence once documents are satisfactory. A complete dossier is what keeps you at the short end.
Classify & Group
We confirm the device’s risk class against CDSCO’s lists and group variants so one licence covers as many models as the rules allow.
Week 1Importer & Agent
Your Indian importer gets its wholesale licence or MD-42 registration, and the overseas manufacturer signs the power of attorney.
Week 1–3Dossier
Device master file, plant master file, free sale certificate, QMS certificate, test reports and labels, prepared to the Fourth Schedule.
Week 2–6MD-14 Filing & Queries
Filed on the CDSCO medical devices portal with the Bharatkosh fee. We answer CDSCO’s queries and arrange any overseas inspection.
After filingMD-15 Grant
The licence is perpetual, with a retention fee every five years. We track retention, endorsements for new devices and post-approval changes.
On grantMedical device manufacturing licences under MDR 2017
Class A & B: State Authority
The State Licensing Authority grants the licence in Form MD-5. A notified body registered with CDSCO audits your quality management system; the authority assigns it, so you can’t choose your own.
Class C & D: CDSCO
CDSCO, as Central Licensing Authority, grants the licence in Form MD-9 after inspecting your factory. Loan licences (MD-6 and MD-10) cover making devices at another licensee’s site.
QMS, Not Just ISO
Your factory must meet the Fifth Schedule quality system. An ISO 13485:2016 certificate isn’t mandatory for a manufacturing licence, but the system it describes is what auditors check.
Prototype & Testing
A test licence (MD-13) lets you make devices for testing, evaluation, demonstration or training, valid for three years. Testing can be done at CDSCO-registered medical device testing labs.
New Devices
A device with no predicate needs clinical investigation permission from CDSCO before it can be licensed, unless CDSCO waives it.
Export
Licensed manufacturers can get free sale, market standing and non-conviction certificates for export, at ₹1,000 per device.
CDSCO import registration beyond medical devices
CDSCO also registers imported cosmetics and drugs through its SUGAM portal.
Cosmetics Import Registration
- Under the Cosmetics Rules, 2020Application in Form COS-1 leads to a registration certificate in Form COS-2.
- Fees$1,000 per category, $50 per variant and $500 per manufacturing site; $5,000 if CDSCO inspects the overseas site.
- ValidityPerpetual, as long as the retention fee is paid before each five-year period ends.
Drug Import Registration
- Registration certificateThe overseas manufacturing site and each drug are registered in Form 41, applied for in Form 40.
- Import licenceThe importer then needs an import licence in Form 10, applied for in Form 8.
- Through SUGAMBoth are filed online on CDSCO’s SUGAM portal under the Drugs Rules, 1945.
What you’ll need, and what CDSCO charges
Fees are set by the Second Schedule of the Medical Devices Rules, 2017 and paid online through Bharatkosh.
Import Dossier, Usually
- Power of attorneyFrom the overseas manufacturer to the Indian authorised agent.
- Free sale certificateFrom the USA, UK, EU, Canada, Japan or Australia, naming the brand where used.
- Device master fileDesign, specifications, risk management, performance and stability data.
- Plant master fileDetails of the manufacturing site and its quality management system.
- QMS and test evidenceQuality system certificate, test reports and batch release data.
- Labels and instructionsMeeting Chapter VI of MDR 2017, with India-specific details.
| Key Government Fees | Amount |
|---|---|
| Import Licence, per Site + per Device | |
| Class A | $1,000 + $50 |
| Class B | $2,000 + $1,000 |
| Class C or D | $3,000 + $1,500 |
| IVD, Class A or B / C or D | $1,000 + $10 / $3,000 + $500 |
| Overseas site inspection | $6,000 |
| Manufacturing Licence, per Site + per Device | |
| Class A or B | ₹5,000 + ₹500 |
| Class C or D | ₹50,000 + ₹1,000 |
| Other | |
| Class A non-sterile, non-measuring registration | No fee |
| Retention, every 5 years | Same as licence fee |
Source: CDSCO medical devices fee schedule. Testing and notified body charges are separate.
CDSCO and State Licensing Authority filings across India
CDSCO headquarters in New Delhi handles import and Class C and D licences, supported by six zonal, four sub-zonal and thirteen port offices. Class A and B manufacturing and sale registrations go to the State Licensing Authority where your site is. We file with both, wherever you are, including:
Why CDSCO applications get stuck
Most queries come back to the same handful of gaps.
Wrong Risk Class
Filing under a lower class than CDSCO’s list, or than IMDRF countries use, triggers queries or rejection.
No Accepted Free Sale Certificate
Without approval in the USA, UK, EU, Canada, Japan or Australia, you need extra safety data or Indian clinical data.
Importer Not Eligible
The importer needs a manufacturing licence, wholesale licence or MD-42 registration before the MD-14 is filed.
Brand Names Not Matching
Brand names in Form MD-14 must appear on the free sale certificate, or be marked not applicable.
Missing Retention Fee
Licences are perpetual only while the five-yearly retention fee is paid on time.
Changes Not Reported
A change in constitution must be reported within 45 days, with a fresh application within 180 days.
Common questions about CDSCO registration
What is CDSCO registration?
Do all medical devices need a CDSCO licence?
How do I get a medical device import licence in India?
How long does a CDSCO import licence take?
What are the CDSCO fees for a medical device import licence?
Is a CDSCO licence valid forever?
Who can be the authorised agent for an overseas manufacturer?
Do medical device distributors need a licence?
Is ISO 13485 mandatory for a CDSCO manufacturing licence?
Does CDSCO regulate software as a medical device?
Find out exactly which CDSCO licence your product needs
Tell us the device or product and whether you import, make or sell it. We’ll confirm the class, licences, total cost and timeline in writing, free.