CDSCO
MEDICAL DEVICE LABEL COMPLIANCE
CliniExperts regulatory advisers help to evaluate all aspects from legal to regulatory compliances for Medical devices/IVD's to meet all the requirements in the form directives, regulations and standards stated by CDSCO.
A medical device labelling product compliance requires tedious paperwork and detailing, right from the application process until the final approval of the label. Manufacturers/importers often find it difficult to keep track of all the requirements. At CliniExperts, we ensure that your medical device labels comply with the guidelines and regulations laid down by the CDSCO. Although imported devices labels can go under many changes during the label compliance, we at CliniExperts make sure that your imports do not get held up due to labelling red tape.
What Is Medical Device Label Compliance?
Product compliance ensures that a product meets all the specified criteria and quality standards as per the guidelines. This ensures that the end consumers get all the necessary details with just one look at the label and there is no vital information that is missed out.
As per the Medical Devices Rules, 2017, any manufacturer or importer of medical devices who wishes to sell them must follow the labeling guidelines laid out for Product Compliance.
Medical device manufacturers or importers must provide the labels of the device and IFU, in compliance with Chapter VI of Labelling of Medical Devices Rules (MDR) 2017. The main purpose is to regulate medical devices labelling.
Number of Check Points
There are 20+ checkpoints as per the MDR 2017 requirements for the importer and manufacturer with regard to warnings, precautions, product details, sterilization, symbols used on the medical device labels etc., and labels and IFU shall comply with additional ISO standard requirements. Few checkpoints are mentioned below:
The full name should be in format as required by the CDSCO.
The details of medical device including its identification and use should be mentioned.
The name of the manufacturer or the importer should be stated with the manufacturing premise address.
All the warnings and precautions should be mentioned for the users handling the medical device.
The accurate values regarding weight, measurements, volumes, number of units, and the number of the medical devices included in a package must be mentioned in the suitable format. All these should be written in the metric system of measurement.
The year and month of manufacturing along with the expiry date should be included with an additional label for the product's shelf life. 6.a - For sterile devices, The date of sterilization should be stated clearly along with the manufacturing date. 6.b - For devices made from stable materials like stainless steel or titanium, and are supplied without sterilization, or for such instruments, it is not required to include the expiry date.
There should be clear demarcation on the medical devices, if they contain a biological or a medical substance.
A distinctive batch number or lot number should be stated after the words ”Lot No" or "Lot" or "Batch No" or "B.No".
The unique storage and handling conditions of the medical device should be included in the statement, if any.
Any medical devices supplied as sterile products should be mentioned as such on the label along with the specific sterilization method used.
It is necessary to mention if the device is for single use or multiple use.
For distribution of a free sample device to a medical professional, the label of the device must say 'Physician's Sample – Not to be sold'.
The manufacturing license number should be included in the label as "Manufacturing License Number" or "Mfg.Lic.No" or by using "M.L."
For any medical devices that are imported, the importing license number and the importer's name with the address, address of actual manufacturing site and date of manufacture, should be included on the label. Any international or national symbols of certification should be on the label, such as the Bureau of Indian Standards or the International Organization for Standardization (ISO)
Why Medical Device Label Compliance Is Important
The primary goal of implementing such labelling compliance is to protect public health and ensure the safety and performance of the In-vitro diagnostic devices under the Medical Devices Rules, 2017.
Essential Tips
Make sure you check the list of required documents specified are present in the suggested manner before applying for product compliance as an importer or manufacturer to make your approval process easy.
For any imported products, the label should include the name and address of the importer, importing license number, and the date of manufacturing along with the manufacturing site address.
The intended use, technical details, and product information are required for conducting the label compliance.
For label compliance, the importer's license/manufacture license/registration number are required.
Indian standards do not allow stickering on the label for any imported product.
Make sure you follow and include all the labelling conditions per the CDSCO before importing. However, some conditions can be added with the help of the stickering process.
In case of difference in symbol labelling on the label and in the IFU, ensure that the product safety is not compromised.
Expert Advise
The importer/manufacturer must follow all the labelling conditions as per the Medical Devices Rules, 2017. However, if the labelling requirement are not met as per the guidelines and standards, CDSCO can suspend or cancel the importer/manufacturing license.
License number of import/manufacture license/reg. number should be included on the label.
Labels and IFU should include the complete list of product details as stated in the Medical Devices Rule, 2017.
Frequently Asked Questions
Can the medical devices' shelf life be stated on the label instead of the manufacturing date?
No, Both the shelf life or expiry date and date of manufacture should be mentioned on the label of the medical device.
What are the requirements for medical devices lebelling in India
All the product labels should follow the criteria mentioned in Chapter VI of Medical Devices Rules, 2017.
Is it mandatory to submit the original label as per Rule 44 for any import of medical devices?
Yes, specimen original label needs to be submitted as per Chapter VI of the Medical Devices Rules, 2017.
Can the importer stick the details of the label on the retail pack?Does the manufacturer have to do the labelling before the imports according to the Indian Standards?
According to Rule-44 (n), the importer can provide the labelling by sticking the label for any imported device. However, if the details are not already printed, the import license number, name, address, and the manufacturer's details with the manufacturing date are necessary to be mentioned.
Do we need to notify regarding a change in labelling conditions, except for those mentioned in the labelling Rule 44, which any importer should be aware of? For instance, can the importer use the universal label for India and the Philippines with a different manufacturer and license number? Should these things be notified to Philippines as well?
Any change in the details requires prior approval from the CDSCO before the labelling. In case of font type, size, colour, and label design, which are not considered significant changes in the Sixth Schedule, prior approval before sticking the label is not required.