The Union Health Ministry has revised rule 109A of the Drugs & Cosmetics Rules to make labelling of medical devices compulsory in India. The Ministry said in the notification that the particular would be printed in indelible ink on the label and sticker on the shelf pack of the medical device. As per the Ministry, the label should carry the proper name of the device; the information essential for the user to identify the device and its use; the name of the manufacturer and the address of the manufacturing premises where the medical device has been manufactured; the actual statement of the exact quantity in terms of measure, weight, volume, number of units, and the number of devices contained in the package shall be expressed in the metric system; and the manufacturing date and expiry date; alternately the label shall carry the shelf life of the device. Also, it should provide, wherever required, an indication that the medical device contains medicinal/biological substances; any special storage/handling conditions applicable to the device. In this write-up, we will discuss the Rules Relating to the Labelling of Medical Device in India.
What is Medical Device Labelling Compliance?
Medical device compliance ensures that a device meets all the specified quality standards and criteria according to the guidelines. This ensures that the end customers get all the essential information with just one look at the label, and no essential details are missed. According to the Medical Devices Rules, 2017, any manufacturers or importers of a medical device who wishes to sell them must follow the labelling guidelines for device compliance. Medical device manufacturers or importers need to provide the labels of the device and instructions of use in compliance with Chapter VI of Labelling of Medical Devices Rules (MDR) 2017. The main objective is to regulate the labelling of Medical Device.
Note: the primary purpose of implementing such labelling compliance is to secure public health and ensure the performance & safety of the In-vitro diagnostic devices per the Medical Devices Rules, 2017.
Checkpoints related to Labelling of Medical Device
There are more than 20+ checkpoints according to the MDR, 2017 requirements for the manufacturer or importer concerning warnings, product information, precautions, sterilisation, and symbol used on the medial device label etc., and labels & instruction of use shall comply with additional ISO Standard requirements. Following are some checkpoints related to the labelling of medical device:
- The full name should be in a format as required by the CDSCO.
- The manufacturer or importer’s name should be mentioned along with the address of the manufacturing premise.
- The information on medical devices, including their identification & use, should be mentioned.
- The accurate values regarding weight, volumes, measurements, number of units and the number of medical devices included in a package need to be mentioned in a suitable format. All these should be written in the metric system of measurement.
- All the warnings & precautions should be mentioned for the customers handling the medical device.
- There should be a clear distinction between the medical devices in case they contain a biological/medical substance.
- The year & month of manufacturing, along with the expiry date, should be included with additional labelling for the product’s shelf life. 6. A – For sterile medical devices, the date of sterilisation should be stated clearly and the manufacturing date. 6. B – For medical devices made from stable raw materials like stainless steel or titanium and supplied without sterilisation, or for such instruments, it is not required to include the expiry date.
- The unique storage & handling conditions of the device should be included in the declaration if any.
- A distinctive batch no. or lot no. should be stated after the words “Lot No” (Lot) or “Batch No” (B.No).
- It is essential to mention whether the medical device is for single use/multiple uses.
- Any medical devices supplied as sterile products should be written on the label and the specific sterilisation method used.
- The manufacturing license no. should be included in the label as “Manufacturing License Number” (Mfg.Lic.No) or by using “M.L.”
- To distribute a free sample device to a medical professional, the label must say ‘Physician’s Sample – Not to be sold’.
- For any medical devices imported, the importing license number & the importer’s name & address, the address of the actual manufacturing unit and the date of manufacture should be included on the label. Any national/ international certification symbols should be on the label, like the Bureau of Indian Standards (BIS) or the International Organization for Standardization (ISO).
Details Regarding Labelling of Medical Device
Benefit and Risk details are information customers need to decide whether to use a medical device or have it used on them. These details also allow the customers to become aware of potential issues with the medical device:
- Risks & benefits to the patient/environment associated with the uses of the medical device.
- Sufficient descriptive details regarding the medical device and its uses.
- Details about maintaining the medical device or identifying potential issues with the medical device.
- Medical devices would not be a good choice for different types of people and situations.
- Alternative therapeutic & diagnostic choices are available
For everyone in the world to understand the information, the labelling of medical device should also contain the manufacturer’s website. These websites need comprehensive information about medical devices, including instructions for use, safety precautions, and multilingual labelling. Pharmaceutical businesses and patients will benefit from the harmonisation of labelling regulations since it simplifies the labelling process, prevents needless duplication of effort, saves time, and lowers costs.