CDSCO
IN-VITRO DIAGNOSTIC KITS 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.
At CliniExperts, our teams constantly update their knowledge concerning the changes and new guidelines to make your process easy and correction-free. At CliniExperts, we make sure that your products comply with the rules and regulations stated by the CDSCO from the very first application process.
What Is IVD Label Compliance?
Label compliance ensures that a product meets all the specified criteria as per the guidelines and maintains quality standards. Any manufacturer or importer of in-vitro diagnostic (IVDs) medical devices who wishes to sell IVDs has to follow the labelling conditions for Product Compliance as per the Medical Devices Rule 2017.
In-vitro medical device manufacturers or importers must provide the labels of the device and IFU, which should comply with Chapter VI of Labelling of Medical Devices Rules (MDR) 2017. The primary purpose is to implement regulation for all medical devices labelling.
Number of Check Points
There are 20+ checkpoints to remember before applying for the labelling product compliance for an IVD medical device. These checkpoints make the approval process easy and hassle-free. checkpoints include precautions, warnings, details, sterilization, symbols and intended use of the IVDs, which should be on the label, and IFU with compliance to ISO standards. Few Check points are listed below
The IVDs name should be in an appropriate format as required by the CDSCO.
The details of IVD device identification and use should be mentioned.
The name of the manufacturer/importer should be stated with the manufacturing premised address.
All the warnings and precautions should be stated for the users handling the IVD medical device.
The accurateterms regarding weight, measurements, volumes, number of units, and the number of the IVDs included in a package should be stated in the correct format and written in the metric measurement system.
The manufacturing year and month 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 considered 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.
A proper indication on the IVDs, if it contains 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 IVDs unique storage and handling conditions should be included in the statement, if any.
Any IVDs supplied as a sterile product should be mentioned as such on the label along with its sterilization method.
It is necessary to mention if the device is for single 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 IVDs to be imported, the importing license number and the importer's namewith 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 Organisation for Standardisation (ISO).
Why IVD 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
Before applying for product compliance as an importer or manufacturer, make sure you check the list of required documents in a specific manner to make your approval process easy.
For any imported products, the label should include the importing license number, the name and address of the importer, and the manufacturing siteaddress with the date of manufacturing.
The technical details, intended use and product information are required for conducting the label compliance.
For label compliance, the importer's license/manufacture license/registration number are required.
For any imported product, Indian standards do not allow stickering on the label.
Before importing, make sure you follow and include all the labelling conditions per the CDSCO. However, some conditions can be added with the help of the stickering process.
Ensure that the product safety is not compromised if there is a difference in symbol labelling on the label and in the IFU.
Expert Advise
The importer/manufacturer should follow the labelling conditions as per the Medical Devices Rule 2017. However, if the labelling requirement is not up to the 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
Whether the shelf life of the IVDs can be stated on the label instead of the manufacturing date?
No, Both the shelf life or expiry date as well as date of manufacture should be mentioned on the label of the in-vitro diagnostics medical device.
What are the labelling requirements for in-vitro diagnostic medical devices in India?
All the product labels should be under the criteria of Chapter VI of Medical Devices Rules, 2017.
Do we require to submit the original label as per Rule 44 for any import of IVDs?
Yes, specimen original label must be submitted according to the Chapter VI of Medical Devices Rules, 2017.
Can the importer stick the details of the label on the retail pack, or 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 approval from the CDSCO before the labelling. However, things like font size, type, colour, and label design are not considered as significant changes in the Sixth Schedule, not requiring a prior approval before sticking the label.