CDSCO Medical Device Labeling Requirements & Standards

Labelling of medical devices in India is not just procedural. Meeting medical device labeling requirements India is essential, as wrong and incomplete labeling can cause delays in clearing customs, prompt CDSCO queries, lead to potential product recalls, and affect safe use. Understanding labeling regulatory requirements for medical devices is critical for all manufacturers exporting to India. Labelling is regulated primarily by the Medical Devices Rules, 2017 and the Legal Metrology (Packaged Commodities) Rules, and in case of imports, pack particulars are important for importer/Indian Authorised Agent (IAA) managing medical device labeling india processes.

Morulaa assists manufacturers/importers to make the content of primary pack, secondary pack and IFU compatible with Indian requirements CDSCO registration and IAA appointment.

Medical Device Labeling Requirements India : Why Compliance Matters

• For safe and intended use of the device

• Necessary for CDSCO process compliance and readiness

• Requirement for importing the device into India

• Allows traceability (batch/lot/serial) for complaint and recall handling

• Prevents fines and shipments rejection due to non compliance to Legal Metrology

What Must Appear Under Medical Device Labeling Requirements India

In terms of practical implementation, the following elements shall be covered: identity, manufacture / importer information, instructions, warnings, and storage instructions. Batch or serial numbers facilitate traceability (which is usually done through CDSCO digital channels such as SUGAM as per your route to file).

Labeling and medical device symbols labeling would typically be composed of three layers of information:

General (usually mandatory)

• Identity and manufacturer information  name/trade name and address; in case of import/importer or IAA name and address in India

• Device information sufficient information about identification of device or package contents

• Traceability informationBatch/Lot code(s) and/or serial number(s)

• Use-by/expiry date in years and months wherever necessary

• Date of manufacture if required (sometimes contained in batch/serial number)

• Storage and handling specific information in the outer packaging

• Safety information, warnings, cautions, expected performance, possible adverse effects

• Operational information installation, maintenance, replacement and calibration where appropriate

• Preparation prior to usee.g. sterilization or calibration of device as appropriate

If applicable

• State of being a sterile product, handling of damaged sterile packages and re sterilization procedure, if possible

• Restrictions on usage, single use, custom made, usage for clinical investigations or demonstration purposes

• Interference or compatibility risks with other medical devices

• For reusable devices cleaning, disinfection and sterilization process

• Radiation emitting details, if applicable

Instructions for use (IFU)if applicable

• Caution when there are changes in performance

• Risks from environmental exposure (EMC, Electrostatic Discharge, Magnetic field interference, etc.)

• Medicinal products used with the device, with the limitations

• Disposal risks

• Medicinal substances incorporated in the device, if any

• Measurement precision; specific training or facility requirement for user

Labeling Regulatory Requirements for Medical devices: MDR 2017 & Legal Metrology

In India, medical device labeling regulations are governed by two overlapping regimes:

Medical Devices Rules, 2017 (within the ambit of the Drugs and Cosmetics regime)risk categorization, licensing/approvals, manufacture, and labeling specific to individual devices in order to ensure their safety and efficacy.

Legal Metrology Act, 2009 and Packaged Commodities Rules accurate labeling of packaged articles (including medical devices that fall under the category of packaged commodities): name and nature, quantity, price related declarations, if any, particulars of the manufacturer/packer/importer and presentation.

Both are important. Compliance with medical device labeling requirements India regarding devices in front of CDSCO cannot substitute for pack declarations under the Legal Metrology regime.

Key Expectations Under Medical Device Labeling Regulations

• Name and Address of Manufacturer, Packer or Importer; Generic Name of the product; Net Quantity; Date of Manufacturing/Packaging; Retail Sale Price where applicable

• When evaluating labeling regulatory requirements for medical devices under Legal Metrology, all mandatory particulars must be visible on the Principal Display Panel, with readable numeral/letter size.

• Appropriate system of measurement (weight/volume/length/number) and measurement specifications where applicable

• Contact information for consumers' complaints (name, address, telephone number and/or e-mail address) on the packaging

• Stickers shall generally not change any mandatory particulars (except few MRPP reduction cases under the law)

• Multi part packs: declarations either on the main pack or/and references on component packs

• Non compliance is punishable as per the provisions of Legal Metrology Act.

• Packaging artwork should be considered as controlled compliance documents and not just marketing tools.

Medical Device Labeling India: CDSCO & MDR Parameters

• Indelible printing of required particulars

• Manufacture/expiry (or shelf life) as applicable; sterile devices indicate sterilization date logic; some durable non sterile devices may not indicate expiry, where permitted by regulation

• Distinctive batch/lot number

• Special storage/handling conditions

• Sterile, if applicable, and method of sterilization, where indicated

• Warnings/precautions

• “Single use”, if applicable

• Physician’s sample labeling, where applicable (“Physician’s Sample Not to be sold”)

• Where applicable for indigenous devices, the manufacturing license number

• For imported devices: import license number, name, address of the importer, and the manufacturing premises information as may be applicable

Under CDSCO medical device labeling regulations, imported device labeling should be planned together with your Indian Authorized Agent and CDSCO registration / import-license pathway.

Medical Device Symbols Labeling, Small Devices, Exports, UDI & Shelf Life

• Symbol: Proper medical device symbols labeling allows internationally accepted medical device symbols to be used where users understand them. See also ISO 15223-1 Labeling Symbols and ISO 20417 Labeling Standard.

• Compact device: When space is an issue, identifying and important safety messages need to take precedence. For compact devices, utilizing medical device symbols labeling ensures safety messages fit within limited packaging space.

• Export: Usually the exported device is subject to the rules of the importing nation, while at the same time carrying the essential identification/manufacturing/license etc. as per Indian exporting guidelines.

• UDI: CDSCO has introduced Unique Device Identification (device identifier + production identifier). Please verify the applicability of UDI requirement to your device from the latest CDSCO notifications.

• Shelf life: Shelf life should not normally be more than 60 months unless there is justification for this from evidence; particular situations could arise when bringing in products that have only a short shelf life left.

• Investigational device/performance study: Investigational devices require certain labels (product name, batch/lot number, manufacture/use by date, storage, manufacturer information, and investigational label where necessary).

Common labeling mistakes we see

• Incorrect or missing label of importer / IAA along with address on import packaging

• Non-compliance with local medical device labeling regulations and failure to include required details on the principal display panel

• IFU not relevant for intended use and/or warnings in India

• Format of batch/expiration date is not harmonized across primary and secondary packs

• Artwork approved prior to CDSCO clarification/query or issuance of license number

• UDI/Logo is not needed for India (copied from EU/USA)

How Morulaa Helps With Medical Device Labeling Requirements India

• Morulaa can assist manufacturers and importers in need of labeling support to meet medical device labeling requirements india across CDSCO, import, and Legal Metrology standards:

• Assessing the primary and secondary pack labels and IFU against medical device labeling india standards

• Preparation of label information for imported products

• Harmonization of product classification and registration/MD-15 filing route

• Alignment with technical documents and QMS documentation, if necessary

• Support for post market changes to the labels based on complaints/FSCA/ regulatory updates

Related services: CDSCO registration | Indian Authorized Agent (IAA) | Post-market surveillance | CDSCO classification | About Morulaa

FAQ

Next step

Lock medical device labeling requirements india early before packaging print and shipment, especially if you are appointing an IAA and filing for import licensing.