Medical Device manufacturers must follow the labeling requirements and must be done on every medical device packaging. An overview of the process for registration of medical devices in India here. The CDSCO is the Indian FDA which handles all regulations for medical devices in India. On 25th September, 2014 the CDSCO issued amendments to the Drugs and Cosmetics Rules, 1945. An important amendment for medical device manufacturers to observe is Rule 109A – labeling requirements.
Medical devices which require registration in India include spinal needles, cochlear implants, annuloplasty rings, trachestomy tubes, syringes and needle, dental implants, surgical sealants, heart valves, cardiac stents, orthopedic implants, endotracheal tubes, and catheters, among others. This article can help you understand the labeling requirements for the registration of medical devices in India. READ ALSO: Notified Medical Devices India, Registration of Medical Devices in India.
Labeling Requirements for Registration of Medical Devices in India
‘109A. Labelling of medical devices.– The CDSCO has issued guidelines for the registration of medical devices in India. As per the updates, the following labeling requirements has to followed and printed on the label or sticker. This labeling must be done on every outer covering in which the medical device is packed.
- Proper name of the medical device is required by the CDSCO;
- The details necessary for the user to identify the device and its use;
- The name of the manufacturer and address of the manufacturing premises where the device has been manufactured is required by the CDSCO for the registration of medical devices in India;
- CDSCO requires the correct statement of 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 shall be expressed in metric system; and the date of manufacture and date of expiry; alternately the label shall bear the shelf life of the product: (a) Provided that in the case of sterile devices the date of sterilization may be given as date of the manufacture of the device (5) Provided further that the device is made up of stable materials such as stainless steel or titanium, and supplied non-sterile, date of expiry may not be necessary;
- To provide, wherever required, an indication that the device contains medicinal or biological substance;
- To provide, a distinctive batch number or lot number preceded by the word “Lot No.” or “Lot” or “Batch No.” or “B. No.”; (a) to indicate, wherever required, any special storage or handling conditions applicable to the device; (b) to indicate, if the device is supplied as a sterile product, its sterile state and the sterilisation method;
- To give, if considered relevant, warnings or precautions for the attention of the user of the medical device;
- To label the device, if the device is intended for single use for the registration of medical devices in India;
- To overprint on the label of the container, the words “FOR CLINICAL INVESTIGATION ONLY”, if the device is intended for clinical investigation;
- To overprint on the label of the device, the words “Physician’s Sample—Not to be sold”, if a medical device is intended for distribution to the medical professional as a free sample;
- To provide, except for imported devices, the manufacturing licence number by preceding the words “Manufacturing Licence Number” or “Mfg. Lic. No.” or “M. L”;
- For the registration of medical devices in India, Devices or In-vitro diagnostics which are not sold to customer or patient directly and are sold for use by hospitals or diagnostic labs shall provide the information affixing additional label or sticker on outer shelf pack;
- To provide on the label, in case of imported devices, with the approval of the licensing authority mentioned in rule 21, the import licence number, name and address of the importer and address of the actual manufacturing premises, date of manufacture, (if not already printed at the time of import) is required for the registration of medical devices in India;
- Provided that the label may bear symbols recognised by the Bureau of Indian Standards or International Organisation for Standardisation (ISO) in lieu of text and the device safety is not compromised by a lack of understanding on the part of the user in case the meaning of the symbol is not obvious to the device user for the registration of medical devices in India.
Custom Made Devices
For the registration of medical devices in India with the CDSCO, we can assist in determining the requirements for custom vs general implants. When the device is specifically made in accordance with a duly qualified medical practitioner’s written prescription under his responsibility, in accordance with specific design characteristics and is intended for the sole use of a particular patient and the label should bear the word “custom made device. As per CDSCO requirements, Mass produced devices which only need adoption to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom made devices. READ ALSO: Documents required for Notified Medical Device Registration in India.