Labelling of Medical Devices in India: A Comprehensive Guide as per Rule 78E of the Medical Devices Rules, 2017

In India, the Medical Devices Rules, 2017 (MDR 2017, notified as G.S.R. 78(E)) regulate every aspect of medical devices—from manufacturing and import to sale and post-market surveillance. One of the most critical yet often overlooked aspects is labelling. Proper labelling ensures patient safety, traceability, and regulatory compliance with the Central Drugs Standard Control Organization (CDSCO).

Labelling requirements are primarily detailed under Rule 44, with supporting provisions for exports (Rule 45), Unique Device Identification (Rule 46), shelf-life restrictions (Rule 47), and investigational devices (Rule 48). This comprehensive guide breaks down everything you need to know about medical device labelling in India.

1. Mandatory Labelling Requirements (Rule 44)

Every medical device sold in India must carry the following particulars in indelible ink on the label, shelf pack, and every outer covering:

Clause	Requirement	Key Points
(a)	Name of the medical device	Exact notified name as per CDSCO classification
(b)	Details to identify the device & its use	Intended use, user instructions (if needed)
(c)	Name & address of manufacturer	Actual manufacturing premises (not just registered office)
(d)	Net quantity	Weight, volume, number of units — only in metric system
(e)	Manufacture & Expiry date	Format: “Expiry date MM/YYYY” or “Shelf Life” → Sterile devices: Date of sterilization can be treated as manufacture date → Stable materials (SS, titanium) or equipment: Expiry not mandatory
(f)	Medicinal/biological substance indication	e.g., “Contains heparin”, “Drug-eluting stent”
(g)	Batch/Lot number	Preceded by “Lot No.” / “Batch No.” / “B.No.”
(h)	Special storage/handling conditions	e.g., “Store below 25°C”, “Protect from light”
(i)	Sterility status & method	“Sterile”, “Sterilized by EO / Gamma”
(j)	Warnings / Precautions	e.g., “Single use only”, “Latex-free”
(k)	Single use indication	“Single Use” or ♻ with bar (ISO 7000-1051)
(l)	Physician sample	“Physician’s Sample — Not to be sold”
(m)	Manufacturing Licence Number (Indian manufacturers)	“Mfg. Lic. No. ML-XXX”
(n)	Import details (via sticker if not pre-printed)	Import licence no., importer name/address, actual manufacturing site, manufacture date

Symbols: BIS/ISO symbols can replace text only if meaning is obvious to the user.

Small-sized devices exemption: If label space is limited, only clauses (a), (b), (c), (d), (e), (g), (k), (m) are mandatory.

2. Labelling for Export (Rule 45)

Devices meant only for export can follow the importing country’s labelling laws, but minimum Indian requirements still apply on the innermost pack and all outer coverings:

Name of device
Batch/Lot/Serial number
Expiry date (if any)
Manufacturer name & actual premises address
Licence number (Lic. No.)
International symbols OK

Special cases (as requested by foreign buyer):

Name/address can be replaced by State code + “Device” + Lic No.
Even code can be replaced by a special coding system approved by Central Licensing Authority (CLA)

3. Unique Device Identification (UDI) – Rule 46

Mandatory from 1st January 2022

Every licensed medical device must bear UDI containing:

Device Identifier (DI) → Global Trade Item Number (GTIN)
Production Identifier (PI) → Serial no. / Lot no. / Software version / Mfg & Expiry date

UDI must appear in both human-readable (HRI) and machine-readable (AIDC) formats (e.g., barcode or DataMatrix).

4. Shelf Life Restrictions (Rule 47)

Maximum shelf life: 60 months (unless justified with stability data & CLA approval)
Import restrictions based on residual shelf life:

Total Shelf Life Claim	Minimum Residual Shelf Life Required at Import
< 90 days	≥ 40%
90 days – 1 year	≥ 50%
> 1 year	≥ 60%

Example: A device with 24-month shelf life must have at least 14.4 months remaining at the time of import.

5. Labelling for Clinical Investigation / Demonstration (Rule 48)

Devices imported/manufactured for test, evaluation, clinical investigation, training, or demo need only the following on the container:

Product name or code
Batch/Lot/Serial number
Manufacture date
Use before date
Storage conditions
Manufacturer name & address
Purpose: “For Clinical Investigation Only” or “For Demonstration Only”

No need for full commercial labelling.

Common Non-Compliances Observed by CDSCO

Missing actual manufacturing premises address
Expiry date in wrong format (e.g., DD/MM/YYYY instead of MM/YYYY)
Using non-metric units (e.g., “10 pcs” without weight/volume)
No UDI on Class C & D devices post-Jan 2022
Import licence number missing on sticker
“Single Use” not mentioned or wrong symbol used
Residual shelf life <60% for long shelf-life devices

Quick Checklist for Labelling Compliance (Rule 78E)

Indelible ink on all packs
All 14 clauses (a) to (n) covered
Metric system only
Expiry: “Expiry date MM/YYYY”
Batch no. with prefix
Sterility + method
Single use symbol/text
Mfg. Lic. No. or Import Lic. No.
UDI (DI + PI) in HRI + AIDC
Residual shelf life ≥60% (for >1 yr devices)
ISO symbols only if meaning is obvious

Conclusion

Labelling is not just a regulatory formality — it’s a patient safety tool. Non-compliant labelling is one of the top reasons for CDSCO detention, cancellation of licences, and import alerts.

Whether you’re a domestic manufacturer or an importer, Rule 78E compliance is non-negotiable.

Pro Tip: Use automated artwork management systems with UDI generators and pre-approved templates to avoid last-minute rejections.

Stay compliant. Stay safe.

Last Updated : 13 Feb 2026

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