HIBCC Pakistan

What HIBCC Pakistan does

HIBCC Pakistan is the international affiliate of HIBCC, Inc. (Health Industry Business Communications Council), a US-based nonprofit founded in 1983 to develop the Health Industry Bar Code (HIBC) Standard. Operating from Lahore, Pakistan, the affiliate serves Pakistani medical device manufacturers — primarily in the surgical, dental, and general medical device segments concentrated in Sialkot — by assigning Labeler Identification Codes (LICs), generating Unique Device Identifiers (UDIs), and providing consultancy for regulatory compliance with US FDA, EU MDR 2017/745, MHRA UK, Australian TGA, Saudi SFDA, and Turkish regulations. The company holds the unique regulatory status of being designated as an Issuing Entity by both the US FDA and the European Commission, positioning it as one of a small number of accredited standards bodies globally for medical device UDI compliance.

The core product portfolio is anchored on the HIBC barcode standard, which supports alphanumeric character encoding and variable data length — features that allow manufacturers to embed existing product identifiers directly without translation or padding. Around this standard, HIBCC Pakistan offers a layered suite of services: GUDID submission to the FDA, EUDAMED registration across six modules (Actor Registration, UDI, Certificate, Clinical Investigation, Vigilance, Market Surveillance), Single Registration Number acquisition, CE Mark certification advisory, 21 CFR 820 quality system consultancy, FDA device registration, barcode services (1D/2D), inspection services (container loading, pre-shipment, DUPRO), and translation services. The business model is built on one-time LIC assignment fees tiered by manufacturer's gross sales to the healthcare industry ($1,000 to $20,000), supplemented by professional services fees. Training sessions and webinars are offered free of charge as a customer acquisition channel. The company has approximately 10 employees and operates as a lean, event-driven consultancy heavily reliant on partnerships with SIMAP, TDAP, and the Lahore Chamber of Commerce.

Name

HIBCC Pakistan

Legal name

HIBCC, Inc.

Website

https://hibccpakistan.org

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Short description

HIBCC Pakistan is a HIBCC International Affiliate that assigns Labeler Identification Codes and provides UDI compliance consultancy to Pakistani medical device manufacturers seeking FDA, EU MDR, and other international regulatory market access.

Ownership category

akta.pro rank

Headquarters

HQ city

Lahore

HQ country

Pakistan

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Marketing or Sales, Operations, Technology or R&D, Infrastructure, Others

Revenue model

1. Labeler Identification Code (LIC) Assignment: One-time fee charged to healthcare industry labelers for assignment of the Labeler Identification Code (LIC), which serves as the company prefix in the HIBC primary data structure and FDA-required UDI. The fee is based on the organization's gross sales volume to the healthcare industry during the previous fiscal year.
2. UDI Technical Support and Services: Ongoing technical support services for UDI compliance including GUDID FDA USA data submission, EUDAMED registration, Single Registration Number (SRN) acquisition, FDA registration, and translation services for regulatory compliance.
3. Training Services: UDI and GUDID training sessions and seminars conducted periodically. Training is provided free of charge as indicated on the training schedule page, suggesting the primary value lies in driving LIC and consultancy service adoption.
4. CE Mark Certification Advisory Services: Customized CE marking advisory services including developing compliance strategies, organizing lab testing and documentation for products to meet EU standards for marketing in the European Economic Area.
5. Inspection Services: Container loading inspection, pre-shipment inspection, and during-production (DUPRO) inspection services for quality and compliance verification.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

HIBCC Pakistan is an international affiliate of HIBCC US that assigns Labeler Identification Codes (LICs) to medical device manufacturers and provides Unique Device Identification (UDI) compliance services. The company's offerings include GUDID and EUDAMED database submission, Single Registration Number acquisition, CE Mark certification advisory, FDA registration support, barcode services, inspection services (container loading, pre-shipment, DUPRO), translation services, and structured training programs. Pricing for the foundational LIC assignment is structured as a one-time fee based on the organization's gross sales to the healthcare industry.

Product overview

HIBCC Pakistan operates as a HIBCC International Affiliate offering a comprehensive suite of regulatory compliance solutions centered on Unique Device Identification (UDI) services. The core product portfolio includes UDI assignment and management, supported by add-on modules for GUDID FDA submission, EUDAMED registration across six modules, Single Registration Number (SRN) services, CE Mark certification, FDA registration, barcode services, inspection services (container loading, pre-shipment, DUPRO), translation services, and training programs. The company provides a complete Labeler Identification Code (LIC) assignment service as the foundational element, with consultancy services for 21 CFR 820 and EU MDR 2017/745 compliance. Pricing is structured on a one-time fee basis based on organization sales volume.

Differentiator

Problem solved

Functional benefit

Products and services

• Labeler Identification Code (LIC) Assignment
• Unique Device Identification (UDI) Services
• EUDAMED Services
• GUDID Services
• Single Registration Number (SRN) Services
• CE Mark Certification Services
• FDA Registration Services
• Barcode Services
• Inspection Services
• Training Services (UDI and GUDID)
• Translation Services
• EU MDR 2017/745 Consultancy
• 21 CFR 820 Consultancy

Named customers5 records

Segments7 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Six partnerships are on record, tiered core and minor.

• SIMAP (Surgical Instruments Manufacturers Association of Pakistan)coreGTM or Marketing Partner · 17 September 2022HIBCC Pakistan collaborates with SIMAP on UDI compliance education for the surgical instruments industry. Activities include co-hosting FDA GUDID seminars, EU MDR 2017/745 awareness sessions, and SIMAP exhibitions. HIBCC conducted a FDA GUDID session at SIMAP on September 17, 2022, and participated in the SIMAP EXHIBITION on August 10, 2023.
• TDAP (Trade Development Authority of Pakistan)coreGTM or Marketing Partner · 1 October 2021HIBCC Pakistan collaborated with TDAP to host an awareness session on EU MDR 2017/745 with the Surgical Association and TDAP's participation. TDAP is a government trade development body that supports Pakistani exporters in meeting international standards.
• LCCI (Lahore Chamber of Commerce and Industries)minorGTM or Marketing Partner · 20 January 2021HIBCC Pakistan conducted a UDI seminar at the Lahore Chamber of Commerce and Industries on January 20, 2021, as part of its UDI awareness campaign targeting the business community in Lahore.
• Surgical Association SialkotminorGTM or Marketing Partner · 1 November 2020HIBCC Pakistan team met with Surgical Association Sialkot office bearers to discuss UDI compliance and EU MDR 2017/745 requirements for the surgical instruments manufacturing industry in Sialkot, Pakistan.
• HIBCC US (Health Industry Business Communications Council)coreOthersHIBCC Pakistan operates as a HIBCC International Affiliate of HIBCC US. HIBCC US is the parent organization that established the HIBC (Health Industry Bar Code) Standard in 1983. HIBCC Pakistan serves as the regional representative for LIC assignment, UDI compliance services, and HIBC standard promotion in Pakistan and the broader South Asian region.
• Bureau VeritasminorStrategic or Co-development PartnerBureau Veritas is referenced as a certification body with over 100 years of experience in helping companies reduce risk and improve business through CE marking services. HIBCC Pakistan's CE Mark certification services page references Bureau Veritas as an example of an experienced CE marking service provider.

Scale indicators3 records

Recent moves6 records

Expansion highlights3 records

Direct peers

• GS1: GS1 is the dominant global barcode standards body and the primary alternative FDA-designated UDI Issuing Entity. It serves the same medical device manufacturers with a competing GTIN-based standard, making it the most direct competitor to HIBCC's HIBC standard in Pakistan and globally.
• HIBCC, Inc. HIBCC, Inc. is the US-based parent nonprofit that established the HIBC standard in 1983 and is the originating Issuing Entity. HIBCC Pakistan operates as its international affiliate, so they share the same underlying standard, customer value proposition, and regulatory designations.

Broad incumbents

• DNV: DNV is a global quality assurance and risk management company providing certification, testing, and inspection services across multiple sectors including healthcare and medical devices. It is a broad incumbent in the certification space.
• SGS: SGS is a leading global TIC firm offering inspection, certification, and testing services across multiple industries including medical devices. It competes with HIBCC Pakistan's inspection and pre-shipment verification services, particularly for medical device exporters.
• Intertek: Intertek is a global TIC provider offering medical device testing, certification, and quality assurance services. It overlaps with HIBCC Pakistan's CE Mark advisory, inspection, and regulatory compliance services for medical device exporters.
• UL (Underwriters Laboratories): UL is a global safety science organization providing testing, inspection, and certification services including for medical devices and healthcare products. It competes with HIBCC Pakistan's certification and quality compliance offerings.
• Bureau Veritas: Bureau Veritas is a global testing, inspection, and certification (TIC) incumbent referenced by HIBCC Pakistan as an example of a CE marking service provider. It competes with HIBCC Pakistan's CE Mark and inspection services offerings across broader industrial verticals.
• TÜV SÜD: TÜV SÜD is a global certification body providing CE marking, MDR compliance, and quality system audits for medical device manufacturers. It is a broad incumbent in the same regulatory compliance space HIBCC Pakistan serves.

Others

• IQVIA: IQVIA is a major life sciences services and consulting firm offering regulatory, quality, and compliance solutions for medical device and pharmaceutical manufacturers. It is a thematically adjacent player rather than a direct barcode/UDI competitor.
• Zebra Technologies: Zebra Technologies is a leading provider of barcode scanners, printers, RFID, and Automatic Identification and Data Capture (AIDC) hardware. It is an enabling technology provider in the same barcode identification ecosystem that HIBCC's HIBC standard serves.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/HibccP
• YouTubeyoutube.com/channel/UCcYcUXQ-YL2wGlxgyZrDf0w
• Facebookfacebook.com/hibccpakistanofficial
• LinkedInlinkedin.com/company/hibcc-pakistan
• Instagraminstagram.com/hibccpakistan

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about HIBCC Pakistan