By Shantam Sharma and Ritvik Kashyap
Introduction
For years, the medical device industry has operated in a regulatory tug-of-war caught between the labelling requirements of the Legal Metrology (Packaged Commodities) Rules, 2011 & amendments thereof (“LM Rules”) and Medical Devices Rules, 2017 (“MD Rules”). This overlap created confusion, inconsistent enforcement, and unnecessary compliance burdens. The Legal Metrology (Packaged Commodities) Amendment Rules, 2025[1] finally break this deadlock. With a decisive and long-awaited clarification, the Government of India has explicitly carved out medical devices from the scope of LM Rules and brought them entirely under the ambit of the MD Rules. This single amendment resets the compliance landscape and brings long-needed certainty for manufacturers, importers and regulators alike.
Key Amendments
The Legal Metrology (Packaged Commodities) Amendment Rules, 2025 introduce four focused but impactful changes. These amendments ensure that wherever a package contains a medical device, the declarations required on the package will be governed exclusively by the MD Rules. The following are the key highlights of the Legal Metrology (Packaged Commodities) Amendment Rules, 2025:
- Declarations for Medical Devices now governed solely by MD Rules
A proviso has been inserted in Rule 2(h) of the LM Rules[2], clarifying that:- For packages containing medical devices, the provisions of the MD Rules shall apply for all declarations.
This removes medical devices from the ambit of general LMPC declaration requirements.
- Height of Numerals and Letters (Rule 7(2) of LM Rules[3])
The amendment inserts a proviso confirming that:- For medical devices, the height of numerals and letters used in declarations will be governed by the MD Rules and not the LM Rules.
This removes the confusion regarding font-size compliance.
- Width of Numerals and Letters (Rule 7(3) of LM Rules[4])
Similarly, a proviso is added stating that:- The width requirements for any numeral or letter on a package containing a medical device shall be determined as per the MD Rules.
This ensures uniform typography standards under a single regulatory framework.
- Exclusion from Relaxation under Rule 33
Rule 33 of LM Rules[5] a new sub-rule (2) has been added, which provides that:- Where the MD Rules applies, the relaxations under Rule 33 will not apply.
This prevents inadvertent extension of LMPC exemptions to medical devices.
What the Medical Devices Rules, 2017 states regarding Declarations
With the Legal Metrology (Packaged Commodities) Amendment Rules, 2025 removing medical devices from the ambit of LM Rules, the MD Rules now operates as the sole regulatory code for labelling and packaging of such products. Rule 46 read with Schedule IV of MD Rules set out a comprehensive list of declarations designed to ensure clarity for consumers.
The MD Rules requires the following declarations on every medical device packaging:
- Name of the medical device;
- Details necessary for the user to identify the device and its intended use;
- Name of the manufacturer and the address of the manufacturing premises;
- Net quantity, expressed in terms of weight, measure, volume, number of units, as applicable, and the number of devices contained in the package, expressed in metric system;
- Month and year of manufacture and expiry, or alternatively the shelf life of the device:
- For sterile devices, the date of sterilisation may be treated as the date of manufacture.
- For devices made of stable materials (e.g., stainless steel, titanium), supplied non-sterile, or for medical equipment/instruments/apparatus, the expiry date may not be necessary.
- The expiry date must refer to the last day of the month and be preceded by “Expiry date” or “Shelf Life.”
- Indication, wherever required, that the device contains a medicinal or biological substance;
- Batch number or lot number, preceded by “Lot No.” / “Lot” / “Batch No.” / “B. No.”;
- Any special storage or handling conditions (if applicable);
- If the device is supplied sterile, an indication of its sterile state and the method of sterilisation;
- Relevant warnings or precautions, where necessary, to draw the user’s attention;
- Appropriate labelling for single-use devices, where the device is intended for single use;
- If the device is intended to be given as a free sample to medical professionals, the package must bear the words:
- “Physician’s Sample – Not to be sold”
- Manufacturing licence number (for domestically manufactured devices), preceded by “Manufacturing Licence Number” / “Mfg. Lic. No.” / “M. L”
- For imported devices, the label must include (which may be provided by stickering):
- Import licence number,
- Name and address of the importer,
- Address of the actual manufacturing premises,
- Date of manufacture.
- Symbols recognised by BIS or ISO may be used in place of text, provided the meaning is clear to the user.
- For small-sized medical devices where full labelling is not possible, the label must still include all essential particulars required for product identification and safety. At a minimum, such devices must display:
- the name of the medical device,
- details needed to identify the device and its intended use,
- the name and address of the manufacturer,
- net quantity,
- manufacturing date and expiry date / shelf life,
- the batch or lot number,
- an indication if the device is intended for single use, and
- the manufacturing licence number (for domestic devices).
Conclusion
The 2025 amendment provides much-needed clarity in an area where regulatory overlap had long created confusion for both industry and enforcement authorities. By expressly excluding medical devices from key LMPC declaration requirements and affirming the exclusive applicability of the Medical Devices Rules, 2017, the Government of India has ensured a sector-specific and harmonised compliance regime. This shift not only reduces the compliance burden but also strengthens consumer safety by ensuring that all medical device labelling aligns with the specialised technical standards prescribed under the MDR. As the industry adapts to this clarified framework, manufacturers and importers will benefit from greater certainty, consistency and regulatory coherence.
[1] Available at: https://consumeraffairs.gov.in/public/upload/files/267107_1761404707.pdf
[2] Principal display panel, available at: https://doca.gov.in/lm-ebook/wp-content/uploads/2024/12/FInal-Book-Legal-Metrology-with-amendments.pdf
[3] Available at: https://doca.gov.in/lm-ebook/wp-content/uploads/2024/12/FInal-Book-Legal-Metrology-with-amendments.pdf
[4] Available at: https://doca.gov.in/lm-ebook/wp-content/uploads/2024/12/FInal-Book-Legal-Metrology-with-amendments.pdf
[5] Power to Relax, available at: https://doca.gov.in/lm-ebook/wp-content/uploads/2024/12/FInal-Book-Legal-Metrology-with-amendments.pdf