Complete Guide to Medical Device Labeling Requirements under MDR 2017/745 (1)

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Regulatory Solution India https//www.regulatory-s
olutions-india.com/
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Labeling Requirements for Medical Devices (wrt
MDR 2017 amendments thereof)

• For the manufacture/import and sale of medical
  devices in India, they must comply with the
  Medical Device Rules, 2017, which are regulated
  by the  Central Drugs Standard Control
  Organization (CDSCO), the national regulatory
  authority under the Ministry of Health and Family
  Welfare. In addition to other requirements,
  medical devices must meet labeling standards
  outlined in these rules before they can be
  manufactured/imported or sold  in India.
• Labeling is crucial for ensuring the safety,
  quality, and regulatory compliance of medical
  devices. In addition to the Medical Device Rules,
  2017, which govern the labeling of medical
  devices in India, the Legal Metrology Act, 2009,
  also emphasizes the importance of proper
  labeling. According to this Act, all pre-packaged
  goods, including medical devices, must adhere to
  prescribed standards for labeling.
• These standards are designed to ensure
  transparency and accountability, enabling
  consumers to make informed decisions. Compliance
  with these regulations is essential not only for
  legal reasons but also for maintaining the
  integrity of the device in the market. For
  further insights into legal metrology compliance,
  read our blog,  A Guide to Legal Metrology
  Compliance for Medical Devices in India, which
  offers practical guidance on meeting these
  important requirements.
• In this blog, we will explore the key labeling
  requirements for medical devices under the
  Medical Device Rules, 2017, and why adherence to
  these standards is essential for manufacturers
  and importers in India.

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What is a Label?

• A label is a comprehensive listing of all
  essential details of a medical device, including
  the devices name, description, intended use,
  safety instructions, manufacturers information,
  risks, precautions, expiry date, and more. This
  information helps in safeguarding both users and
  patients.
• Now that we understand what a label is, lets
  explore the specific labeling requirements set
  out by the Medical Device Rules, 2017.

What are the Labeling Requirements for Medical
Devices?

• The labeling requirements for medical
  devices under the Medical Device Rules, 2017, are
  as follows
• On the outer cover of the medical device, the
  following particulars should be printed in
  indelible ink
• Name of the medical device
• The details necessary for the user to identify
  the device and its use
• Name and address of the manufacturer and address
  of the actual manufacturing premises

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• The correct statement about the net quantity in
  terms of weight, measure, volume, number of
  units, as the case may be, and the number of the
  devices contained in the package expressed in
  metric system
• The month and year of manufacture and expiry
  (alternately the label shall bear the shelf life
  of the product)
• In case of sterile devices, the date of
  sterilization may be given as date of manufacture
  of the device
• Provide wherever necessary, an indication that
  the device contains medicinal or biological
  substance
• Indicate, wherever required, any special storage
  or handling conditions applicable to the device
• Indicate, if the device is supplied sterile, its
  sterile state and the sterilization method.
• Give, if considered relevant, warnings or
  precautions to draw the attention of the user of
  medical device

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• Provide a distinctive batch number or lot number
• Print Unique Device Identification with effect
  from such date as ordered by the Central
  Government.
• Label the device appropriately, if the device is
  intended for single use
• Provide, except for imported devices, the
  manufacturing license number
• The import licence number, name and address of
  the importer, address of the actual manufacturing
  premises and the date of manufacture
• The label may bear symbols recognized by the
  Bureau of Indian Standards or the International
  Organization for Standardization (ISO).

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Why Labelling a Medical Device is Crucial?

• Labeling is important to ensure the safe and
  informed use of medical devices by healthcare
  professionals and patients. Lets understand why
  labeling a medical device is so crucial
• Patient Safety The primary goal of labeling a
  medical device is to provide critical information
  to healthcare professionals and patients
  regarding its usage, handling, storage, and
  maintenance. This helps prevent misuse and errors
  and reduces the risk of adverse events.
• Regulatory Compliance Labeling is an integral
  part of the Medical Devices Rules, 2017, which
  must be properly followed by manufacturers and
  importers. Non-compliance with labeling
  requirements may lead to serious legal
  consequences, including recalls and penal
  charges.
• Traceability Labels ensure the traceability of a
  medical device through its batch number, lot
  number, and unique device identification (UDI),
  which allows manufacturers to quickly address any
  potential defects or malfunctions.
• Risk Management Labels include information such
  as warnings, contraindications, and precautions
  that help mitigate risks and protect patients
  from potential harm.
• Handling and Storage Instructions Labels provide
  important information on how to handle, store,
  and maintain the device so that it can function
  properly as intended.

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How Regulatory Solutions India Can Help You?

• Regulatory Solutions India (RSI) has been a
  trusted partner for medical device manufacturers
  and importers since 2011. We are well-versed in
  the labeling requirements set by CDSCO. We can
  assist you in preparing and submitting the
  required documentation for regulatory approval,
  ensuring that the label meets the specific
  criteria for approval by regulatory bodies.
• Partner with us to ensure the safety, compliance,
  and success of your medical devices in the Indian
  market. Visit us at Regulatory Solutions India.  

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