Medical Device Classification in India
How are medical devices classified in India?
India sorts medical devices into four risk classes under Rule 4 of the Medical Devices Rules, 2017 (G.S.R. 78(E), 31 January 2017): Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). Non-IVD devices are classed using Part I of the First Schedule and in vitro diagnostics using Part II. The Central Licensing Authority (the DCGI) assigns each device its class based on its intended use, and CDSCO publishes the class lists on its website (MDR 2017, p. 8).
Approach: I couldn't open the copy of the Rules held in our datasets this time, so I read the text of the Rules published on CDSCO's website. I took the device examples from CDSCO's published risk-classification lists. I did not check how far later amendments to the Rules are reflected in that copy.
Legal basis: Rule 4
- Rule 4(1): devices other than IVDs are classified A to D using the parameters in Part I of the First Schedule.
- Rule 4(2): IVDs are classified A to D using Part II of the First Schedule.
- Rule 4(3): the Central Licensing Authority classifies devices "based on the intended use of the device and other parameters specified in the First Schedule".
- Rule 4(4): CDSCO publishes class-wise lists on its website. The Authority may add or delete devices or change a device's class at any time.
- Rule 5: devices can be grouped for licence applications, following Ministry of Health guidelines (pp. 8-9).
Part I: devices other than IVDs (pp. 54-62)
Basic principles
- The device's intended purpose decides the class.
- Combination devices and accessories are each classified on their own.
- Software that drives or influences a device takes the device's class.
- A device not limited to one body part is classed on its most critical use.
- If more than one rule applies, the strictest rule (the higher class) wins.
Use-duration terms are defined in Rule 3 (p. 7):
- Transient: less than 60 minutes.
- Short term: 60 minutes to 30 days.
- Long term: more than 30 days.
The 18 parameter groups
| # | Device type | Usual class, with key shifts |
|---|---|---|
| (i) | Non-invasive, in contact with injured skin | A if the wound has not breached the dermis; B if it has, or for wound micro-environment management; C if it has breached the dermis and cannot heal by primary intention |
| (ii) | Non-invasive, channelling or storing substances | A; B if connected to an active Class B/C/D device or used for blood, body liquids or organs; C for blood bags without a medicinal product |
| (iii) | Non-invasive, modifying blood or body liquids | C; B if the change is by filtration, centrifuging, or gas or heat exchange |
| (iv) | Other non-invasive | A (no contact, or intact skin only) |
| (v)-(vii) | Invasive via a body orifice (transient / short / long term) | A / B / C. Shifts: eyeball surface or absorbed by mucosa moves transient up to B; oral, ear or nasal cavity without mucosal absorption moves short term down to A and long term down to B |
| (viii) | Body-orifice device connected to an active Class B/C/D device | B, whatever the duration |
| (ix) | Surgically invasive, transient | B; A for reusable surgical instruments; C for ionising radiation, a biological effect or absorption, or hazardous drug delivery; D for direct contact with the CNS, heart or central circulation |
| (x) | Surgically invasive, short term | B; C if it changes chemically in the body (B if placed in a tooth), delivers medicine or ionising radiation; D for a biological effect, absorption, or CNS/heart/central circulation contact |
| (xi) | Implantable or long-term surgically invasive | C; B if placed in a tooth; D if in contact with the heart, central circulation or CNS, life-supporting or life-sustaining, active, absorbed, delivering medicine, a breast implant, or changing chemically in the body |
| (xii) | Active therapeutic, giving or exchanging energy | B; C if done in a potentially hazardous way (e.g. ionising radiation) or if it controls a Class C therapeutic device |
| (xiii) | Active diagnostic | B; A if it only illuminates with visible or near-infrared light; C for monitoring vital parameters where changes mean immediate danger, diagnosis of a patient in immediate danger, or ionising radiation in diagnostic or interventional radiology. Active devices giving or removing medicines or body liquids are B, or C if this is potentially hazardous |
| (xiv) | Other active devices | A |
| (xv) | Containing a medicinal product with ancillary action | D; B if the medicine is exempt from licensing under the Drugs and Cosmetics Act |
| (xvi) | Containing animal, human, microbial or recombinant cells, tissues or derivatives | D; A if made from non-viable animal tissue that touches intact skin only |
| (xvii) | Sterilisation or disinfection | C (sterilising devices, end-point disinfection, contact-lens care); B if it disinfects before sterilisation or end-point disinfection |
| (xviii) | Contraception or STD prevention | C; D if implantable or invasive for long-term use |
Part II: in vitro diagnostics (pp. 62-65)
Basic principles
- Intended purpose decides the class, and accessories are classed separately.
- Software follows the device it drives.
- Standalone analysis software takes the class of the IVD whose output it controls or influences.
- Calibrators take the class of the reagent they are used with.
- If more than one rule applies, the stricter rule (higher class) wins.
The rules
- Class D: tests for transmissible agents that screen blood, tissues or organs for transfusion or transplant; tests for agents causing life-threatening disease with high risk of spread; blood grouping or tissue typing for the ABO, Duffy, Kell, Kidd and rhesus systems.
- Class C:
- sexually transmitted agents;
- infectious agents in CSF or blood with limited spread;
- infections where a wrong result risks death or severe disability;
- prenatal immune status;
- cancer screening and diagnosis;
- human genetic testing;
- critical therapeutic drug or marker monitoring;
- HIV/HCV viral load and genotyping;
- congenital disorder screening;
- other blood grouping or tissue typing;
- self-testing;
- near-patient blood gas or blood glucose testing.
- Class B: self-tests that do not determine a medically critical status, or give preliminary results needing laboratory confirmation; any IVD not covered by another rule.
- Class A: reagents or articles with specific characteristics for an IVD procedure, instruments for IVD procedures, and specimen receptacles.
Examples from CDSCO's published lists (Rule 4(4))
- Non-IVD devices:
- IVDs: setting changes the class. An alcohol body-fluid analyser is Class A for laboratory use but Class C for near-patient testing [9][10]. ABO and Rhesus (D) blood-grouping reagents are Class D [11][12].
What the class affects
- Who licenses: the Central Licensing Authority handles import of all classes and manufacture of Class C and D devices (Rule 8, p. 9). Notified Bodies audit domestic Class A and B manufacturing sites (Third Schedule, p. 69).
- Documents: Class A applications need a shorter document set. Class B, C and D applications also need a device master file (Fourth Schedule, pp. 73-75).
- Fees: fees depend on the class (Second Schedule). For example, a manufacturing licence costs INR 5,000 per site for Class A/B and INR 50,000 per site for Class C/D (p. 66).
If you have a specific device, I can look up its class in CDSCO's published lists.
Sources:
How do I find which class my device is in?
You don't decide the class yourself. In India only the Central Licensing Authority (CLA) classifies medical devices. You find your device in CDSCO's published risk-classification lists, and if it isn't listed, you ask the CLA to classify it [13]. The steps are below.
Approach: I used CDSCO's Medical Device and IVD FAQs and the two risk-classification lists CDSCO publishes (one for medical devices, one for IVDs). I couldn't open the copy of the Medical Devices Rules, 2017 in our datasets this time, so references to the Rules point to the text on CDSCO's website.
Step 1: Search the right CDSCO list
- Non-IVD devices: use the medical device risk-classification list.
- IVDs: use the separate IVD list.
- Each entry gives a device category, the device name, an intended-use statement and the class under MDR 2017. For example:
- The CLA can add or delete devices or change a device's class at any time, so the lists keep changing [16]. This is in Rule 4(4) of the Rules (CDSCO text, p. 8).
Step 2: Match on intended use, not just the name
- The CLA classifies on intended use plus the First Schedule parameters [16].
- The same product name can appear more than once with different intended uses. For example, "Glucose test reagents/kits" has one entry for estimating glucose in blood, plasma or body fluids and another for preliminary self-testing. Both are Class B [17][18].
- Compare your label and instructions for use (IFU) with the intended-use wording in the entry, not only the device name.
Step 3: If your device isn't listed, ask the CLA
- Send a separate request to the CLA with:
- the product's technical documents (label and IFU);
- the regulatory status of the product, or a similar product, in other countries.
- The CLA tells you the class and updates the published list [13].
- CDSCO's FAQ says to confirm that your device is on a published list before applying for marketing authorisation, and to ask the CLA if it isn't [19].
Points to watch
- Test licence class doesn't count: the class on a test licence (MD-13/MD-17) is only the class you proposed during development. It cannot be used for marketing authorisation [19].
- Veterinary devices: the same First Schedule parameters and the same published classes apply to devices used on animals [20].
- Self-classifying: you can work through the First Schedule rules from my previous answer to estimate the class before you apply. CDSCO says only the CLA can classify, though [13], so treat your estimate as a working assumption until the CLA confirms it.
If you tell me the device name and intended use, I'll search both CDSCO lists for matching entries.
What's an example of a Class A device?
A cotton crepe bandage is a typical Class A device in India. CDSCO's risk-classification list puts it under General Hospital/Orthopedics, with the intended use "for sprains, strains and painful joints on intact skin" [1].
Approach: I searched CDSCO's published risk-classification list for medical devices (other than IVDs) under the Medical Devices Rules, 2017.
Other Class A entries on the same list
- Elastic adhesive bandage: for securing dressings and strapping on intact skin [21].
- Plaster of Paris bandage: for supporting a fractured body part [2].
- Eye pad: a gauze or cotton pad worn over the eye for protection or to absorb secretions [22].
- Tongue depressor (ENT): moves the tongue so the surrounding organs can be examined [23].
- Foetal stethoscope: a mechanical device for listening to the fetal heartbeat [24].
- Infant inguinal hernia truss: a single-use strap worn over the groin [25].
Why intended use matters: similar products can fall in a different class. A liquid bandage for minor cuts, abrasions and blisters is Class B [4]. A negative pressure wound therapy bandage is Class C [26]. An electronic oesophageal stethoscope is Class B, while the mechanical foetal stethoscope is Class A [27].
I can pull Class A examples for a particular device category, such as dental or ophthalmic devices, or for IVDs.