HIBCC Industry News
Although our scope has expanded beyond the initial HIBC labeling mandate issued 30 years ago, we have continued to emphasize ‘safety first’ through the years.
As such, the Health Industry Business Communication Council has an important advocacy and educational role in today’s healthcare industry. We are proud to act as the forum through which consensus can be reached as all parties work together to ensure a safer, more efficient industry.
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The European Commission published an FAQ document for implementing and satisfying the UDI System requirements set forth in the EU Medical Device Regulations 2017/745 and 2017/746. The FAQ document covers compliance dates, the Basic UDI-DI, labeling requirements, and other important information for medical device manufacturers. To view the complete FAQ document click here. To learn.. read more →
HIBCC will be speaking about UDI at the following meetings in September 2019. Sydney, Australia – September 18 & 19, 2019 HIBCC President Robert Hankin will be speaking on UDI implementation at the 2019 MedTech Conference, as well as leading a pre-conference workshop (attendance at the workshop is limited to MTAA members). He will focus.. read more →
HIBCC has updated its user account page to provide HIN users with the ability to add related identifiers to their Customer HIN Lists (CHLs). The CHL was designed to allow licensed HIN users to create and manage their customer HINs without having to search and sort the entire HIN database. Each CHL is specific to.. read more →
HIBCC has established a new mailbox – email@example.com – for inquiries and technical support related to the European Union Medical Device Regulation (MDR). The use of this mailbox will streamline requests for both new EU-MDR registrations and support for existing users. read more →
The EHIBCC website, formerly www.ehibcc.com, has been consolidated with that of HIBCC Global. The European Commission has designated HIBCC to be a Unique Device Identifier (UDI) Issuing Agency as part of the European Union Medical Device Regulation (MDR), which will apply to all EU member nations. To learn more about HIBCC and UDI, visit www.hibcc.org.. read more →
HIBCC is pleased to announce that it has appointed a Pakistan-Based affiliate organization, in cooperation with QMSCI (Quality Management System Certification International), a long-standing regulatory and engineering consulting company that is headquartered in Sialkot, PK and also has offices in several other countries. QMSCI has created a new organization, HIBCC Pakistan (HIBCC PK). HIBCC PK.. read more →
- 27 Jan 2020Notice to Labelers: HIBCC Contact Information
- 14 Jan 2020The European Commission announces the European Medical Device Nomenclature (EMDN)
- 17 Dec 2019How to use HIN for Drug Supply Chain Security Act (DSCSA) requirements
- 04 Dec 2019European Commission releases updated EUDAMED Data Dictionary
- 05 Nov 2019HIBC Basic UDI-DI Guidance and Generator Now Available to Meet European Union Requirements