Medical Device Labelling is an essential documents that is mandatory to provide by the manufacturer. The information that label contains that is about the medical device purpose, usage, risks, and maintenance. This labelling ensures that safety and effective use of healthcare professionals. Medical device companies that willing to sell their product in market must adhere to regulations supplied by the CDSCO for labelling medical devices.
Medical Device or equipment Labelling is the term used to describe text that is displayed on a device, such as symbols, instructions, warnings, control data, and more. The device can be labelled using coding, printing, machining, injection moulding, and other techniques. The primary information that is absolutely necessary for the user is displayed by the printed symbols or instructions.
Medical device regulations make sure that a device satisfies all requirements for quality and performance. This makes sure that no important details are missed and that end users can quickly and easily gather all the information they need from the label. according to the medical device rule.
If you are dealing in medical device manufacturing then let us explain you that medical device labelling plays a crucial for several reasons:
The CDSCO, under the Ministry of Health and Family Welfare, oversees the regulation of medical devices in India. The labelling requirements for medical devices are outlined in the Medical Devices Rules, 2017, which align with international standards to ensure consistency and safety.
As per the medical device rules, 2017, labelling of medical devices must include the following items:
Here we are talking about the medical devices and few of the medical device may have additional labelling requirements based on their nature and intended use
For the imported medical devices the CDSCO has mandate the labels must be in english and to the same standards as those required for domestically manufactured devices. The product must contain the additional information such as name and address of the Indian importer.
A device’s label, packaging, or directly marked on the device itself may contain an alpha-numeric or numeric code that represents both in plain text that is readable by humans and a machine-readable format, such as codes, linear, two dimensions, or RFID technology. The distribution and uses of a device are used by UDI to identify it. Product recalls and the reporting of adverse events is greatly simplified by the UDI system. This is a useful factor for locating a product on the market based on how it is distributed and used. As a side effect, the system is already included in the 2017 Medical Device Rule.
Any importers and manufacturers of medical devices who wish to distribute them must adhere to the device certification labelling requirements. Manufacturers or importers of medical devices must comply with Chapter VI of the 2017 Labelling of Medical Devices Rules (MDR) by providing the device’s labels and usage instructions. The primary goal is to control medical device labelling. On sept 25, 2014 CDSCO Issued the drugs and cosmetic rules 1945. A significant Amendment is currently being implemented to comply with the 109A labelling requirement .Notifide medical devices rules india Rules.pdf
Medical devices and IVD that must be registeration and labelling include IV set cannulas, surgical drapes, needle injection systems, blood bag systems, heart valves, catheters, cardiac stents, Pacemaker, and surgical sealant. This article can assist you in understanding the labelling requirements for medical devices in India.
Many medical devices and IVD are developed or researched to be used by patients at home, unattended by a healthcare provider. To ensure proper use and safety, patients, medical professionals i.e doctors, Pharmacist and nurse and any medical staff , are experienced users all require clear instructions , directions, and warnings. Devices that are handled carelessly or Improperly run the risk of damaging or harming the user. While serious harm or even death are possible risks with some devices, even relatively minor mistakes can have a negative effect on patient outcomes. Nothing should be more important to all parties involved in the device manufacturing process than the well-being of their end users. Effective labeling procedures reduce negative experiences across the board. Additionally, they will keep you in compliance with the local regulatory body, avoiding any expensive delays, damaging recalls, or other legal implications.
Manufacturer & Importer may face several challenges in adhering to medical device labelling:
Users need benefits and danger information before deciding whether to use or be treated with a medical device. Following details are aware of customers.
Key components that must be mentioned in the medical device labelling include the device name, manufacturer’s details, batch number, expiry date, instructions for use, warnings, and storage conditions.
YES, certain devices like vitro diagnostics, implantables, and electromedical devices have an additional labelling requirement based on their nature and use.
Challenges include complex regulations, language barriers, and the integration of technology. Engaging with experts and using professional services can help address these issues.
