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 requirements 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.
What is a Label?
A label is a comprehensive listing of all essential details of a medical device, including the device’s name, description, intended use, safety instructions, manufacturer’s information, risks, precautions, expiry date, and more. This information helps in safeguarding both users and patients.
Now that we understand what a label is, let’s 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;
- 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;
- 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).
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. Let’s 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.
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 here.
