India Labelling under Rule 44 and Sticker Labelling

1. Key takeaways

Indian labelling requirements for medical devices are set out in Chapter VI (Rules 44 to 48) of the Medical Devices Rules, 2017. The particulars must be printed in indelible ink on the label, or on the shelf pack of the device, or on the outer packaging and every outer layer of packaging. For imported devices, Rule 44(n) allows the importer to add, by stickering, the import licence number, the name and address of the importer, the address of the actual manufacturing site, and the date of manufacture, where those details are not already printed.

• Chapter VI governs labelling for devices generally, and it applies to exempt Class A products as well.
• Stickering is a genuine concession for importers and removes the need for India-specific printing at the factory.
• Only details that are not already printed may be added by sticker; the base label still has to be complete.
• Expiry must be expressed as month and year, preceded by the words Expiry date or Shelf Life.
• Chapter VI is not among the chapters exempted for Class A devices, so labelling compliance survives the exemption.

2. Legal basis

The labelling obligations sit in Chapter VI and are elaborated in the CDSCO’s published FAQ answers. The table below sets out the specific matters, their sources, and what each requires.

3. Expert insights

Insight one: stickering is a significant convenience granted to importers. It means the overseas manufacturer does not need to print market-specific packaging carrying the Indian licence number. The import licence number, the importer information, and the date of manufacture can be applied by the importer after the goods arrive at port. For exporters with small batches and wide product ranges, this is a material cost saving, because a single factory label design can serve the Indian market alongside others without a separate print run.

Insight two: what is stickered is “details not already printed”, not the entire label. The wording of Rule 44(n) is “when such details are not already printed” — it applies only to the missing portions. Baseline elements such as the product name, the manufacturer, the batch number, and the expiry date must still be printed on the original label. Importers who treat the sticker as a complete label replacement are misreading the provision, and the error usually surfaces at customs or during a post-market inspection.

Insight three: Chapter VI still applies to exempt products. Although Class A products that are neither sterile nor measuring are exempt from the manufacturing and import licensing chapters, the labelling chapter, Chapter VI, is not on the exemption list — the CDSCO FAQ question 69 identifies chapters IV, V, VII, VIII, and XI as the exempted ones. Products taking the exemption route must still get their labelling right. The exemption reduces the licensing burden; it does not reduce the labelling obligation.

Insight four: the expiry format is mandatory. Only the month and the year are written, and the words “Expiry date” or “Shelf Life” must precede them. Writing DD/MM/YY is non-compliant. The requirement looks trivial, yet it is a fixed, checkable formatting rule, and it is one of the few labelling points that a reviewer can verify at a glance without any technical context.

4. Practical recommendations

GRZAN structures the labelling solution for clients in two layers. The factory layer carries the product name, the manufacturer name and address, the net content, the batch or serial number, the month and year of manufacture, the month and year of expiry, storage conditions, warnings and precautions, and the intended use. The sticker layer carries the import licence number, the importer name and address, the actual manufacturing site address, and the date of manufacture. We produce the sticker artwork as a print-ready file matched to actual practice at Indian ports of entry, and we specify the sticker position, so that the goods are not treated as repackaged during clearance.

• Separate the label artwork into a factory layer and a sticker layer from the outset.
• Confirm that every baseline element remains printed on the original label before adding a sticker.
• Match the sticker artwork to port practice and specify placement to avoid repackaging findings.
• Check that wording for exempt Class A products still satisfies Chapter VI.
• Verify the expiry field format against Rule 44(e) before the artwork is released.

5. Verification checklist

• □ The factory label already contains the product name, manufacturer, batch number, and expiry date
• □ The expiry is in month plus year format and is preceded by Expiry date or Shelf Life
• □ The sticker artwork contains the import licence number, importer name and address, actual manufacturing site address, and date of manufacture
• □ The label is printed in indelible ink on the label, shelf pack, and outer packaging
• □ Exempt Class A products have been confirmed as still subject to the Chapter VI labelling requirements

Regulatory information verified as of 27 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including India. Our team prepares dossiers to CDSCO expectations, manages SUGAM submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com