Medical Device Registration and Manufacturing Licence in India
Medical device registration in India means getting your device onto the Medical Devices Online portal under the right class: a simple registration number for low-risk Class A items, or a manufacturing licence in Form MD-5 or MD-9 for everything else. We classify the device, prepare the file and see the application through to grant.
What it is
Under notification S.O. 648(E) of 11 February 2020, every medical device sold in India is regulated as a drug under the Drugs and Cosmetics Act, 1940, and licensed under the Medical Devices Rules, 2017. Licensing became compulsory for Class A and B devices from 1 October 2022 and for Class C and D devices from 1 October 2023.
Rule 4 sorts devices by risk: Class A low, Class B low-moderate, Class C moderate-high and Class D high. The First Schedule classes them by intended use, invasiveness and duration of contact. The class decides who licenses you. The State Licensing Authority handles Class A and B manufacture; the Central Licensing Authority at CDSCO handles Class C and D. All applications are made on the Medical Devices Online portal, cdscomdonline.gov.in.
Who it applies to
You make a simple Class A device
If it is non-sterile and non-measuring, you need no licence. You enter the device details on the portal and receive a system-generated registration number, with no fee. Labelling rules still apply.
You make other Class A or Class B devices
You apply to the State Licensing Authority in Form MD-3 and receive a manufacturing licence in Form MD-5. A loan licence uses Form MD-4 and is granted in Form MD-6.
You make Class C or Class D devices
You apply to CDSCO in Form MD-7 and receive a manufacturing licence in Form MD-9. A loan licence uses Form MD-8 and is granted in Form MD-10.
Why it matters
Stay on the right side of the Act
Making or selling a device without the licence the rules require is an offence. Under Section 27(b) of the Act it can mean three to five years in prison.
Show buyers a number they can check
Rule 44 puts your manufacturing licence number on the label, where buyers can check it.
Get it once, keep it
No renewals. Licences stay valid in perpetuity, as long as the retention fee is paid every five years.
Which route fits your device class
The class of your device fixes the form, the authority and whether a site audit happens before grant.
| Class | Apply in | Licence | Authority | Audit or inspection |
|---|---|---|---|---|
| A (non-sterile, non-measuring) | Portal entry | Registration number | Online portal | None |
| A (sterile or measuring) | MD-3 | MD-5 | State Licensing Authority | Notified body audit within 120 days after grant |
| B | MD-3 | MD-5 | State Licensing Authority | Notified body audit within 90 days of application, before grant |
| C and D | MD-7 | MD-9 | CDSCO | Inspection within 60 days of application |
Here is the catch: a Class A device that is sterile or has a measuring function is not in the easy group. It needs a full licence.
Take a Faridabad unit planning a Class B product. It files Form MD-3, a notified body audits the plant within 90 days, and the licence follows within 20 days of the audit report. Unsure of the class? We check your device against CDSCO’s classification lists and the First Schedule.
Documents required
About the company and site
- Constitution document of the manufacturer (company, LLP or firm)
- Ownership or rent papers for the manufacturing site, and site layout
- Other licences for the premises, such as a factory licence where it applies
- Details of qualified technical staff
About the device
- Device Master File: description, specifications, design, labelling, risk analysis, verification and validation
- Labels, instructions for use and test reports
About quality
- Plant Master File describing the site and processes
- Undertaking that the Fifth Schedule quality management system is in place
- ISO 13485 certification, where you hold it
How it works
Classify the device
We confirm the intended use and class from CDSCO’s lists and the First Schedule. It sets the whole route.
Get the site and QMS ready
Your plant must follow the Fifth Schedule quality management system and have qualified technical staff. Your quality consultant builds the systems; we track what the dossier needs.
Prepare the master files
You or your consultant write the Device and Plant Master Files; we check them against the Fourth Schedule and index them for upload.
File on the portal and pay
We file Form MD-3 or MD-7 on cdscomdonline.gov.in and pay the Second Schedule fee online.
Get through the audit or inspection
For Class B, a notified body registered with CDSCO audits the site. For Class C and D, CDSCO inspects. In practice, our work here is coordinating dates, sharing paperwork and helping you close observations.
Put the licence number to work
The licence number goes on your labels. We track reportable changes, new devices and the five-year retention fee.
Timelines
Class A licence
Rule 20 requires a decision within 45 days of the application. The notified body audit follows within 120 days of grant.
Class B licence
The notified body audits within 90 days of the application. The State Licensing Authority then grants Form MD-5 within 20 days of the audit report.
Class C and D licence
CDSCO inspects the site within 60 days of the application and decides within 45 days of the inspection report (Rules 23 and 25).
What happens if you skip it
Criminal liability
Section 27(b) of the Drugs and Cosmetics Act, 1940: three to five years in prison and a fine of at least ₹1 lakh or three times the value of goods confiscated, whichever is more.
Stock seized
Inspectors can seize unlicensed stock.
Buyers hold back
Hospitals and distributors look for the licence number on the label. Without it, orders stall.
Frequently asked questions
Is medical device registration compulsory in India?
Yes. Under S.O. 648(E) of 11 February 2020, all medical devices are regulated under the Medical Devices Rules, 2017. Licensing became mandatory for Class A and B devices from 1 October 2022 and for Class C and D from 1 October 2023. Only Class A non-sterile, non-measuring devices get a simpler route: a free, system-generated registration number. Everything else needs a licence.
How do I find out the class of my device?
Start with the product-wise classification lists CDSCO publishes on its website, grouped by speciality. If your device is not listed, the First Schedule rules decide the class based on intended use, invasiveness and duration of contact. We review your labelling and claims and give you a reasoned class before you file.
Who issues the licence for Class A and B devices?
The State Licensing Authority of the state where you manufacture. You still apply on the central Medical Devices Online portal in Form MD-3, and the licence comes in Form MD-5. For a Faridabad plant, that is Haryana’s. A notified body registered with CDSCO audits the site, before grant for Class B and within 120 days after grant for Class A.
What is a notified body?
A notified body is a conformity assessment body registered with CDSCO under the Medical Devices Rules, 2017 to audit manufacturing sites of Class A and Class B devices. Only bodies on CDSCO’s registered list can do these audits, and the list changes over time. You pick and pay the notified body directly; we help you shortlist from the current list and prepare the site paperwork they will review.
Do I need ISO 13485 for a licence?
The rules require your site to follow the quality management system in the Fifth Schedule of the Medical Devices Rules, 2017, and you give an undertaking to that effect with the application. An ISO 13485 certificate is useful evidence, but the audit or inspection checks the Fifth Schedule requirements on site.
How long is a manufacturing licence valid?
It stays valid in perpetuity unless it is suspended or cancelled. The holder must pay a retention fee every five years, equal to the site and per-device licence fees: ₹5,000 per site and ₹500 per device for Class A or B, and ₹50,000 per site and ₹1,000 per device for Class C or D. We diarise the date so the retention fee is never missed.
Can I add a new device to my existing licence?
Yes. You apply on the portal to add the new device, with its Device Master File and the per-device fee from the Second Schedule. Class C or D additions go to CDSCO; Class A or B additions go to the State Licensing Authority. We prepare the addition and update your records.
I only trade in medical devices. What do I need?
Say you run a Ballabgarh firm that only distributes medical devices to hospitals and holds no drug sale licence. Then you need a registration certificate in Form MD-42 from the State Licensing Authority. You apply in Form MD-41 on the portal, and CDSCO’s FAQ says it should be issued within ten days. It is perpetual, with a retention fee every five years. We file these for traders too.
Can I make a few units for testing before I get a licence?
Yes, with a test licence. Under Rule 31 you apply in Form MD-12 and receive Form MD-13, which lets you make a device for clinical investigation, test, evaluation, demonstration or training. The government fee is ₹500 per distinct device. These units cannot be sold. We file the test licence early so your trials do not hold up the main application.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Government fees under the Second Schedule of the Medical Devices Rules, 2017:
| Licence | Per site | Per distinct device |
|---|---|---|
| Class A non-sterile, non-measuring registration | Nil | Nil |
| Class A or B manufacturing (MD-3 / MD-4) | ₹5,000 | ₹500 |
| Class C or D manufacturing (MD-7 / MD-8) | ₹50,000 | ₹1,000 |
| Test licence (MD-12) | – | ₹500 |
Notified body audit charges are separate and paid to the notified body.
Ready to begin?
Send us the device brochure and where you plan to make it. We will confirm the class, the form and the government fee within a working day.