IVD Labeling Compliance | In Vitro Diagnostic Device Labeling Requirements

About IVD Labeling Compliance Or In Vitro Diagnostic Device Labeling Requirements –

Central Drug and Standard Control Organization (CDSCO) is the regulatory body of India that works under the control of the Ministry of Health and Family Welfare (MoHFW). CDSCO follows the Drug and Cosmetic Act 1940 and Rules 1945, along with Medical Device Regulation 2017. The primary responsibility of CDSCO is to regulate the manufacture and import of medical devices and In-vitro diagnostic (IVD) in India. Not only manufacturing and import but other activities such as testing, standard compliance, labelling compliance, transportation, storage and packaging should also be noticed by the CDSCO. CDSCO ensures that medical devices and IVDs being marketed are safe and effective to be used by the population and do not cause any serious harm, injury or death. That’s why it is important to ensure CDSCO compliance before applying for a license.

What is IVD Labeling compliance / In Vitro Diagnostic Device Labeling?

Under the Drug and Cosmetics Act,1940 In vitro diagnostic (IVD) are defined as the substances intended to be used outside human or animals’ bodies for the diagnosis of any diseases or disorder or conditions. IVDs are covered under the section (3) clause (b) sub clause (i).IVDs that are notified, from time to time, as a device are covered under section (3) clause (b) sub-clause (iv). Like medical devices, IVDs too have different rules, regulations and standards that need to be followed if anyone wants to sell or distribute the IVDs. The rules and regulations mainly focus on the testing, registration, storage, transportation, labeling, import and manufacture of IVD in India to establish that they are safe and effective to use. IVDs are used to detect diseases, conditions and infections and help medical professionals to release their IVDs in the market. CDSCO released medical device rules in 2017, briefly explaining the labeling of the IVD. As new players are coming to the market, CDSCO does want to avoid any misinformation to the people. That’s why CDSCO has specifically given regulatory requirements in a chapter of MDR,2017, which are discussed below. The labeling of IVD is the same as medical devices in India given under Chapter VI in MDR,2017.

In Vitro Diagnostic Device Labeling Requirements – IVD Compliance

Given below are the following details that shall be printed on the label with an indelible ink, on the shelf pack or the outer cover of the IVD and on every outer covering in which the IVD is packed, namely: —

1. IVD name;
2. Details necessary for the user to identify the device and its use;
3. Manufacturer name and manufacturing address where IVD has been manufactured.
4. Correct net quantity in terms of weight, measurement, volume, number of units, number of devices in the package,
5. Manufacturing month and year, expiry date (shelf life);
6. In the case of sterilization, the sterilization date shall be given as the manufacturing date.
7. If the IVD contains biological or medicinal substances, an indication is needed.
8. A typical batch number, lot number preceded by “Lot No.” or “Lot” or “Batch No.” or “B. No.”
9. To indicate special storage or handling conditions applicable to the IVD.
10. To indicate if IVD is supplied as a sterile product, its sterile state and sterilization method.
11. To provide relevant warnings or precautions to draw the attention of the user;
12. To label the device appropriately if the device is intended for single use;
13. To print the label of IVD with “Physician’s Sample—Not to be sold” if the IVD is intended for distribution to the medical professional.
14. For imported IVD, the label should be stuck where these details still need to be printed. The label should have an IVD import license number, the importer’s name and address, the manufacturing unit’s address, and the manufacturing date.
15. In the case of small-sized IVDs, the information cannot be printed legally. It shall include the necessary information to identify the product covered by above stated clauses.

Exemptions from IVD Labeling Compliance

The label on a package of IVDs used for export shall contain the information and meet the specific regulatory requirements of the country to which the IVD is being exported. But there are a few details that shall be present on the label, such as:

1. IVD name
2. Batch or lot number
3. Expiry date
4. Name and address of manufacturer and manufacturing unit
5. License number
6. Symbols recognized internationally instead of text, wherever required
7. Other information such as unique device identifier, shelf-life;

Note: 

1. In January 2019, CDSCO released a notice GSR 30(E) drafted specific rules for e-ifu. As IFU is a part of the labelling, it is important for manufacturers and importers to keep in mind the rules of e-ifu.

Why IVD Label Compliance Required?

The main aim of IVD label compliance is to ensure that the label on IVD comply with all the requirements so that there is no room for mistake. CDSCO wants to ensure that all IVD is safe and effective to use and gives correct results, so they insist on following the MDR 2017 rules. IVD helps diagnose diseases and conditions and also supports medical professionals in deciding the route for treatment for patients. Manufacturers and importers need to avoid mistakes at any cost. Thus, it is advisable to contact experienced people with enough experience handling the labeling requirements for IVD. A slight mistake can lead to a delay in the marketing of the device or cancellation as well.