Globizz News
December 24, 2024
HQ Office Holiday Closure
Globizz Headquarters will be closed for Christmas and New Year's.
December 24 - 25, 2024
December 31st, 2024 - January 2nd, 2025
For inquiries during the holidays, please contact the various locations (Tokyo office: [email protected]/ Korea office: [email protected]) or we will respond to you after the holidays.
Happy Holidays!
November 28, 2024
Thanksgiving Holiday Notice
Globizz headquarters will be closed for Thanksgiving during the following periods.
November 28th - December 1st, 2024
For inquiries during the holidays, please contact the various locations (Tokyo office: [email protected]/ Korea office: [email protected]) or we will respond to you after the holidays.
Happy Holidays!
November 19, 2024
Report "MEDICA 2024"
Globizz participated one of the largest medical device event, "MEDICA 2024," from 11/11-14.
Various medical device companies from around the world gathered to provide and exchange the latest medical device information, and there were so many medical device exhibits that it was impossible to visit them all during the event.
Please stay tuned for more upcoming events.
October 25, 2024
The update of EPA Pesticide Bilingual label rules
We want to bring your attention to an important update about pesticide labeling that could significantly impact your operations. The Pesticide Registration Improvement Act of 2022 (PRIA 5) mandates that the health and safety sections of pesticide product labels be translated into Spanish, effective December 29, 2025. With Spanish being the primary language for most American farmworkers, this requirement aims to make vital health information more accessible, ensuring better understanding and compliance of safety instructions.
Starting December 29, 2025, product labels on restricted use and highly toxic pesticide products will be required to bear Spanish language translations for the health and safety sections. This rollout will occur in phases, prioritizing the most hazardous products first. By 2030, all pesticide labels must include these translations, either directly on the container or via a readily accessible electronic link.
At Globizz, we’re here to help you navigate the new bilingual labeling rule for pesticides. Our consulting services can provide you with the guidance and support you need to ensure compliance, making the transition as smooth as possible.
October 24, 2024
Reminder about FDA Medical Device/Drug/Food Facility Registrations
Attention to owners, operators, or agents of both domestic and foreign facilities involved in manufacturing/processing, packing, or storing Medical Device/Drug/Food for human or animal consumption in the U.S. must register with the FDA. Registrations and renewals are open from October 1 to December 31, 2024.
Facility Registration is very important for the FDA to trace the location and potential source of incident. Facilities should submit additional information to the FDA and renew registrations every one(device, drug) or two(food) years.
Ensure your facility registration remains valid. – if you don’t renew by December 31, FDA will mark your product as expired. Globizz is registered as a US Agent for Medical Device/Drug/Food facility registrations. Whether you’re registering for the first time or renewing your existing registration, we can help.
November 11-14, 2024
Globizz will be at "MEDICA 2024"
Globizz will be at "MEDICA 2024," a leading medical device exhibition of the 4th Industrial Revolution era, showcasing everything from the latest medical devices to cutting-edge digital health solutions.
Held at the Düsseldorf Exhibition Centre in Germany, MEDICA boasts the world’s largest exhibition space for medical devices. From November 11th to 14th, this event will bring together thousands of exhibitors and hundreds of thousands of visitors.
In-person meetings are available upon request.
From medical device manufacturers to hospital representatives, physicians, researchers or startups interested in healthcare solutions, or anyone involved in the medical device industry, don't miss MEDICA 2024. We look forward to seeing you there!
- Date: November 11 - 14 2024
- Location: Messe Dusseldorf, Germany, U.S. Department of Commerce Booth (HALL15 / J43)
- Website: MEDICA 2024
October 18-20, 2024
Seminar Speaker: KIMES Busan 2024
The Busan Medical Device Exhibition, 'KIMES Busan 2024,' aimed at improving public health, advancing medical science, and revitalizing the local medical and hospital-related industries, will be held for three days from Friday, October 18 to Sunday, October 20, at the BEXCO Exhibition Center 1 in Busan.
As the largest medical industry exhibition in the region, KIMES Busan attracts over 10,000 visitors each year, including healthcare professionals, industry stakeholders, buyers, and dealers. More than 260 domestic and international companies will participate, showcasing the latest medical devices and healthcare information.
During the same period, participating companies, including Globizz, will hold seminars on various topics related to medical devices in the seminar rooms within the exhibition hall.
- Date: October 18 - 20, 2024
- Location: Busan BEXCO Exhibition Center 1
- Website: KIMES Busan 2024
September 11, 2024
Report:
Sponsored by US Embassy: U.S. Medical Device Anuual Seminar
~ US Market is Your Gateway to the World ~
The seminar was very well attended and we received great feedback from the participants.
We would like to thank everyone who attended.
Please stay tuned for more upcoming events.
September 9, 2024
EU Medical Device Regulatory Compliance Consulting Event
The guest speaker of the seminar on 9/6 is consulting your current or future medical device business plan in EU.
MDR or IVDR are very complicated and these often prevent medical device companies from facing challenges. Mr. András is a specialist in this field and this will be a rare consulting opportunity where you can ask him questions about EU regulations in person.
Globizz bilingual consultants will also be there to help you understand your needs.
- Date/Time: September 9, 2024 (Monday) 3pm-5pm
- Location: Globizz Japan, Tokyo office MAP
- Pre-interview: MDR, IVDR regulations and benefit of obtaining EU regulatory approvals
September 6, 2024
Sponsored by US Embassy: U.S. Medical Device Anuual Seminar
~ US Market is Your Gateway to the World ~
The 11th annual U.S. Medical Device Advancement Seminar, sponsored by the U.S. Embassy and hosted by Globizz, will be held on September 6, 2024.
This year's seminar, themed “US Market is Your Gateway to the World,” will cover the latest trends in FDA regulations and key points of the US medical device business, as well as an overview of the European Medical Device Regulation (MDR) and the benefits of FDA approval, with guest speakers providing detailed explanations.
We look forward to your participation in this informative training and information exchange opportunity for those who are planning entering the U.S. market and for companies interested in future expansion into the U.S.
- Date: September 6, 2024 3pm-6pm
- Location: Globizz Japan, Tokyo office MAP
- Sponsored by Globizz
- Supported by US Embassy, Qtics Medical
- Event Details: Invitation & Programs(PDF)
- Pre-interview: MDR, IVDR regulations and benefit of obtaining EU regulatory approvals
3/14 - 3/17/2024
One of the Major Medical Trade Shows in Asia "KIMES 2024" Speaker
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.
- Date: March 14 - March 17, 2024
- Location: COEX, Seoul (South Korea)
- KIMES 2024 Information
- Please reach "Contact" for any questions.
2/1/2024
The largest medical technology conference in Hungary "The Opportunities and Challenges 2024" Lecturer
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.
12/28/2023
Office Closure During Holidays
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!
11/14/2023
FDA’s announcement on MoCRA (Modernization of Cosmetics Regulation Act)
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.
10/18/2023
Globizz visits ISAZI (a business partner in India) and Globizz launches the India project
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.
10/6/2023
FDA Medical Device Seminar
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.
9/22/2023
MDR/FDA Regulatory Education Forum for Overseas Expansion of Medical Devices hosted by KTL
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
