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KIMES 2024, one of the largest medical device events in Asia, will be held by the Korean government.

At KIMES, attendees will see a wide range of medical devices, equipment and technologies from domestic and international exhibitors, including innovations in medical imaging, diagnostic equipment, surgical instruments, healthcare IT solutions and rehabilitation equipment, to name a few.

Globizz is invited to be one of the speakers at this event and will talk about medical devices in the USA and the regulations.

 



In 2024, the Opportunities and Challenges Conference will be held for the 6th time, the aim of which is to inform those working in the health industry and medical technology about domestic and international innovations, regulatory environment, development resources, and the actualities of official procedures, i.e. about the opportunities and challenges determining the work of professionals operating in the field.

Globizz will be a lecturer at this event as a US FDA medical device regulation expert.

About the conference in Hungary



Globizz offices are closed during holiday seasons.

U.S. HQ/San Francisco office: December 28, 2023 - January 2, 2024
Globizz Japan Tokyo/Osaka: December 28, 2023 - Janurary 3, 2024

Any questions we receive during the office closure will be returned after Janurary 2, 2024.

Please have great holidays!



The FDA issued the guidelines for registering and listing cosmetics facilities in August 2023. After issuing the draft guidelines, the FDA collected opinions and evaluated the draft. In September 2023, the FDA gathered opinions on Cosmetics Direct and Forms 5066 and 5067. FDA was in the process of being reviewed by the Office of Management and Budget (OMB).

In October 2023, the FDA issued Structured Product Labeling (SPL) and certification procedures. When FDA begins accepting data in the future, SPL form submissions will be available. They will be available through the FDA's ESG or SPL completion software. They will be available through the FDA's ESG or SPL completion software.



Globizz visited ISAZI in India, with which Globizz has a business partnership since 2021. ISAZI is a pharmaceutical consulting company based in India.

In India, Globizz received very warm hospitality and welcome from ISAZI.

Globizz aims to further expand our business as a pharmaceutical consulting company. Globizz will support companies from all over the world, including U.S. companies, to expand their businesses into India.



On September 22, Globizz lectured about FDA-related topics at the KTL seminar in Seoul, Korea.

We covered topics such as the FDA registration process, the preparations for FDA 510(k), and business expansion in the U.S. Many medical device companies in Korea attended the seminar.

We deeply appreciate your interest in Globizz FDA & US Business seminar. We look forward to supporting your business growth.



Please join "MDR/FDA Regulatory Education for Overseas Expansion of Medical Devices" seminar hosted by Korean Testing Laboratory (KTL).

1st Session: "European Medical Device Certification (CE MDR) Current status and countermeasures"
2nd Session: "Preparartion to enter the U.S. medical device market" by Globizz

Forum Date: September 22, 2023 (KST)
Location: KTL Seoul Branch (Address: Digital-ro 26-gil 87, Guro-gu, Seoul)

Contact: KTL Page




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