FAQ’s

What are the HIBC Standards and HIBCC?

The term “HIBCC” stands for the Health Industry Business Communications Council, which is the main standard-setting and educational organization for digital coding in the healthcare sector.

A group of national trade organizations founded us in 1983 to develop a labelling strategy that would meet the specific requirements of the industry. The Health Industry Bar Code (HIBC) Standard is the result of this study. Millions of items throughout the world and in the business today have the HIBC Standard mark.

Why does healthcare need its own labeling standard?

As Health Industry is unique. Unlike most other industries, healthcare products have special human safety requirements, are routinely monitored by government regulators, and are often “purchased” indirectly (through insurance claims) for patients in hospitals and other healthcare facilities. As a consequence, labels must be as error-free as possible, must contain additional information, and must satisfy greater needs than those commonly found in point-of-sale environments such as grocery check-out counters.
By utilizing the HIBC format, manufacturers and distributors are meeting these requirements while simultaneously using the system which best suits their own internal needs.
In short, everyone in the supply channel benefits from the HIBC Standard.

What Are The Fees For The HIBCC?

We only demand a ONE-TIME FEE from our labelers, and the amount is based on the organization’s sales volume during the previous year.

How Can I Prepare To Be An HIBCC Labeler?

For a complete copy of the HIBC Supplier Labeling Standard, get in touch with HIBCC Pakistan. Follow these four simple steps to apply for your company’s Labeler Identification Code (LIC).

You can either fill out the application form online and submit it through our website or download it from the resources section and email it to sales@hibccpakistan.org, along with documentation of your company’s sales turnover.

Every Manufacturer:

The LIC charge is calculated based on sales revenue to the healthcare industry. Include all divisional sales and sales to other manufacturers when computing sales; exclude intracompany sales.

For wholesalers and distributors:

The LIC charge is based on the gross sales of packaged goods with a private label.

1. HIBCC Will Send Out A Bill
2. Client Is In Charge Of The Lic Fee.
3. The Client Can Generate Udi After Lic Approval.

Explain the UDI?

A string of numeric or alphanumeric characters is produced by the device identifying and coding standard that was used to create the UDI. It makes it possible to precisely identify a specific medical device’s market. The UDI is composed of the UDI-DI and UDI-PI. It is also possible to provide the universally applicable unique title’s serial number or lot information.

What does UDI-DI expressly mean?

A device’s UDI device identifier (UDI-DI) contains details about the device.

What is UDI-PI?

A device’s production information is provided by a UDI production identifier (UDI-PI). The UDI-PI contains data such as the manufacturing date, expiry date, amount, lot number, etc.

What is the Basic UDI-DI?

The Basic UDI-DI is the main access key for device-related information in the EUDAMED database and it is referenced in relevant documentation [e.g. certificates (including certificate of free sale), EU declaration of conformity, technical documentation and summary of safety and (clinical) performance)]. It is intended to identify and connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics. It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item. Any Basic UDI-DI shall identify the devices (group) covered by that Basic UDI-DI in a unique manner.

Which Products Are Exposed Under The UDI System’s Criticism?

All devices, except those used for performance studies and research, must comply with UDI regulations.

Who is in charge of maintaining UDI Compliance?

According to EU MDR 2017/745, the manufacturer is responsible for complying with all UDI-related laws. Examples of these include assigning the UDI (and Basic UDI-DI), registering the UDI (and Basic UDI-DI) in the EUDAMED database, and placing the UDI carrier on the item’s label, packaging, or, in the case of reusable devices, the device itself (direct marking). What structure must a UDI have on a product’s label or packaging?

UDI Carriers On Both

Labels, devices, and higher tiers of device packaging must all include AIDC (Automatic Identification and Data Capture) 

Labels, devices, and higher tiers of device packaging must all include AIDC (Automatic Identification and Data Capture) 

What Modifications To The Medical Device Called For A New UDI-DI?

Every time a modification can lead to a mistaken identification of the object or a hazy traceability, a new UDI-DI is required. Particularly whenever any of the following elements change, a new UDI-DI will be needed: name or trade name, device version or model, labelled as single-use, packaged sterile, the need for sterilization prior to use, number of devices included in a package, critical warnings or contra-indications, and CMR/Endocrine disruptors. Each UDI-DI shall be linked to one and only one Basic UDI-DI.

Reusable Objects That Are Directly Marked. Exist Any Exceptions?

A UDI carrier must be present on the actual reusable device. In order to prepare the device for subsequent use throughout the device’s intended use lifetime, the UDI carrier for reusable devices that need to be cleaned, sanitized, or repaired in between patient uses must stay in place and be readable after each procedure. Throughout normal use and the anticipated lifespan of the (reusable) device, the UDI carrier must remain readable.

The following conditions prevent the requirements from being applied to the equipment: 

• Any Direct Marking Would Compromise The Device’s Functionality Or Safety; 
• The Device Cannot Be Directly Marked Due To Technological Limitations.

What products are required to comply with the UDI Rule?

All devices covered by the 21 USC 321 definition are subject to the UDI Rule unless an exemption or replacement has been authorised (h).

What Components Make Up A UDI?

According to 21 CFR 801.3, a UDI on a device label or container is made up of two components:

The Device Identifier (DI), which is a necessary, fixed component of a UDI that identifies (1) the labeler and (2) the specific version or model of a device, is one of two elements of a UDI. The other portion is the Production Identifier(s) (PI), which is conditional. On a device’s label, the PI must additionally include the following information.

Does The Device Label Have A Standard Format For Dates?

When a medical device’s label includes a printed expiration date, date of manufacture, or any other date that needs to be made clear to the user, the format must be as follows: the day, using two digits; the month, using two numbers; the year, using four numerals; each separated by a hyphen. For instance, 2014-01-02 should be used to refer to January 2, 2014. This regulation only applies to dates that are written in plain language on the device label..

 

Dates are excluded from these data format requirements, including dates found in the device history record and the AIDC technology portion of the UDI. The labeler may choose the field’s last day of the month if a medical device expires in a specified month but not on a specific date because the date field is a requirement of the new format. All medical devices shall utilise the standard date format unless specifically exempted. By the device’s UDI compliance date, this label adjustment must be made.

What Exactly Is A Device Package?

For the UDI label and GUDID submission requirements, device packages contain a certain version or model of a device in a predetermined quantity.. The numerous packaging configurations, or each different form of package, must have a distinctive identity for a device to be adequately identified throughout distribution and use under 21 CFR 801.20(a) (2).

Example:

If a device is provided in separate device packages, boxes of thirty devices, and cartons that comprise twelve boxes of thirty device packages, a separate DI must be displayed on each of the three different types of packing.

Does A UDI Have To Be On Single-Use Devices?

A UDI must normally be printed on the label of a single-use item. One common exception to this rule is the provision of individual single-use devices in a single device packaging that they are intended to be stored in until being removed for use. On the device box, the UDI is still necessary, but not on the label. This exclusion is not applicable to any implanted devices.

What Format Should a UDI Have on a Device Label and Packaging for a Device?

According to the criteria of 21 CFR 801.40(a), each UDI must be provided in both a plain-text version and an AIDC-enabled form. An AIDC is any system that uses technology to convey a device’s unique identifier or device identifier in a way that allows it to be automatically entered into an electronic patient record or other computer system.

People can easily read the readable characters in the plain text. The UDI does not specify a font or point size; rather, it would be governed by the same rules that presently apply to labels for medical devices, such as 21 CFR 801.15, which addresses the prominence of necessary labels.

What Automatic Detection Data Capture (AIDC) systems are needed for Universal Digital Identifiers?

The FDA USA does not specify which AIDC technologies may be used because the most appropriate technology will vary greatly depending on the type of device and its intended applications, and because the available technologies are likely to evolve and advance over time. An alternative to AIDC technology is a bar code that accomplishes the same things.

What modifications might demand a new device identifier?

According to 21 CFR 830.50(a), “[you] must assign a new [DI] to the new version or model anytime you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model.” According to 21 CFR 801.3, a “version or model” is any device that complies with the labeler’s requirements for performance, size, and composition. It is up to the labeler to decide whether device updates or modifications count as different models or versions.