Class and route
Find the likely risk class of your device under the Medical Devices Rules, 2017, the licence and the form you apply on, the standards that apply and the route step by step.
Sending opens our enquiry form with this result already in it. Nothing is sent until you press send there.
How this works
It reads the rules, not a guess
Each answer is read against the classification parameters in the First Schedule of the Medical Devices Rules, 2017. Where the rules do not settle it, it shows every class still open rather than pick one.
Carried from Intended use
If you used the intended use builder first, the answers it can carry are already filled in and marked. Check them, and change any that are wrong.
Private
It runs in your browser. Your answers live only in the address of this page, and move to the next tool only when you follow its link. Nothing is sent to us unless you choose to send it.
What each class means for the licence
| Risk class | Who licenses it | You apply on | The licence is | Before it is granted |
|---|---|---|---|---|
| Class A | State Licensing Authority | Form MD-3 | Form MD-5 | The site is not audited before the licence is granted. A Notified Body audits it within one hundred and twenty days after. |
| Class B | State Licensing Authority | Form MD-3 | Form MD-5 | A Notified Body audits the site before the licence is granted. |
| Class C and D | Central Licensing Authority | Form MD-7 | Form MD-9 | Medical Device Officers inspect the site before the licence is granted, and the Central Licensing Authority may bring in experts. |
What this does not read
- A device connected to an active device takes a class from the one it is connected to. Answering that needs the class of the other device, which is the question you came here with.First Schedule, Part I, paragraphs 1(ii)(b), 1(v), 1(vi), 1(vii), 1(viii) and 1(ix)(c)
- A device that controls, monitors or directly influences a Class C active therapeutic device is itself Class C.First Schedule, Part I, paragraph 1(xii)(c)
- A device that controls, monitors or directly influences a device that emits ionising radiation for radiology is Class C.First Schedule, Part I, paragraph 1(xiii)(e)
- A device incorporating a medicinal product is Class B, not Class D, when that medicine is exempt from licensing under the Drugs and Cosmetics Act, 1940. This checker reads the Class D case only, so it reads high rather than low.First Schedule, Part I, paragraph 1(xv)(b)
Words used on this page
- body orifice
- Any natural opening in the body, including the surface of the eye, and any permanent artificial opening such as a stoma. That is the definition the rules use.
- central circulatory system
- The heart and the great vessels around it, which carry the whole of the circulation.
- dermis
- The layer of skin under the surface. A wound that has not reached it is shallow.
- HLA
- Human leukocyte antigens, the tissue types matched between a donor and a recipient before a transplant.
- ionising radiation
- Radiation with enough energy to strip electrons from atoms, such as X-rays and gamma rays. Visible light, infrared, ultrasound and radio waves are not ionising.
- near-patient testing
- A test done outside a laboratory, in a clinic or at the patient's home, with a result fast enough to change what is done straight away. That is the definition in rule 3.
- non-viable
- No longer living, and not able to become living again.
- Notified Body
- An organisation registered with the Central Licensing Authority to audit medical device manufacturing sites.
- recombinant
- Made by putting genetic material from more than one source into a cell, which then produces the material.
- stoma
- An opening made surgically through the abdominal wall, which stays open.
Other tools
Each one answers a different question in the same scoping conversation, and each runs in your browser.
Questions about class and route
Are my answers sent to you?
No. The tool runs in your browser and does not send your answers to us. The site's analytics counts page visits, and whether a tool was started or finished, without cookies. It does not see what you enter.
Is a result a regulatory determination?
No. It is a reading of the rules against your answers. It cannot see your device or your files. The class is decided in your regulatory file, and the class-wise list CDSCO publishes decides where your device is on it.
Why did it not give one class?
Some answers leave the class open, and a reading that is too low sends you to the wrong authority with the wrong dossier. It then shows every class still possible and the question that would settle it.
Can two similar devices have different classes?
Yes. The class follows the intended use, so the same technology claimed for different uses can fall in different classes.
What about the EU, the US and the UK?
Each sets its own class and route. Send us your result with the markets you want, and we reply with the route for each.