Globizz News
3/8/2026
Business Hours Update Due to U.S. Daylight Saving Time
Daylight Saving Time began in the United States on March 8.
As a result, the business hours of our U.S. headquarters have been updated as follows:
U.S. Headquarters (Pacific Daylight Time)
Monday–Thursday: 9:30 AM – 6:30 PM
Friday: 9:00 AM – 6:00 PM
There are no changes to the business hours of our Tokyo and Korea offices.
11/27/2025
Globizz Group: Holiday Closure Notice: USA, Japan, Korea
We will be closed during the following holiday periods:
U.S. Headquarters / GLOBIZZ Corp.
- Thanksgiving: Nov 27 (Thursday) – Nov 30 (Sunday)
- Christmas: December 24 (Tuesday) – December 25 (Wednesday)
- New Year: December 31 (Wednesday), 2025 – January 4 (Sun), 2026
Tokyo / Osaka / GLOBIZZ Japan
- December 30 (Tuesday), 2025 – January 4 (Sunday), 2026
Seoul / GLOBIZZ Korea
- January 1 (Thursday), 2026
We will respond to any inquiries received during the holiday period as we resume operations after the break.
We apologize for any inconvenience this may cause and appreciate your understanding.
11/22/2025
Globizz Signs MOU with Korea Digital Health Industry Association (KoDHIA) to Strengthen U.S. Market Support
On November 13, 2025, Globizz signed a Memorandum of Understanding (MOU) with the Korea Digital Health Industry Association (KoDHIA) and held an official signing ceremony.
KoDHIA is Korea’s first specialized organization dedicated to digital health. It brings together innovative companies, healthcare institutions, and academic organizations to strengthen industry vitality and enhance national competitiveness. Through policy advocacy, market research, networking events, and talent development programs, KoDHIA is building a robust ecosystem for the digital health sector.
Under this MOU, Globizz will support Korean digital health and medical device manufacturers in entering the U.S. market. The partnership also includes collaboration on U.S. market entry seminars and related events in Korea.
Following the signing ceremony, Globizz hosted a seminar for KoDHIA member companies, attended by approximately 40 participants, including Software as a Medical Device (SaMD) manufacturers. The seminar provided practical insights into U.S. regulatory requirements and market entry strategies.
Globizz remains committed to fostering international partnerships and supporting the global expansion of the medical device industry.
11/12/2025
FDA Announces Measures to Accelerate Biosimilar Development and Reduce Drug Costs
The U.S. Food and Drug Administration (FDA) has announced new efforts to promote the development of biosimilars aimed at lowering drug prices in the United States. These efforts include simplifying biosimilar studies, reducing the number of clinical trials required, and facilitating the development of biosimilars that are interchangeable with high-cost biologic medicines.
Read the News: "FDA Announces Measures to Accelerate Biosimilar Development and Reduce Drug Costs"
10/8/2025
FDA Warning Regarding Risks of Using Unapproved Blood Pressure Measurement Devices
On September 16, 2025, the U.S. Food and Drug Administration (FDA) issued a warning to consumers and healthcare professionals regarding unapproved medical devices that claim to measure blood pressure.
Read the News: "FDA Warning Regarding Risks of Using Unapproved Blood Pressure Measurement Devices"
9/5/2025
US FDA updates food labeling surveillance program for the first time in 14 years
For the first time in 14 years, the US Food and Drug Administration (FDA) has significantly revised its compliance program for monitoring and inspecting food labelling. The latest regulations and operational guidelines for ensuring the accuracy and consistency of food labelling are reflected in the revision.
Read the News: "FDA Updates General Food Labeling Requirements Compliance Program"
8/25/2025
FDA issues Warning Letters to multiple companies for CGMP and QSR violations
FDA issued Warning Letters to several pharmaceutical and medical device manufacturers, as well as online pharmacies, for violations of Current Good Manufacturing Practices (CGMP), Quality System Regulations (QSR), and the illegal sale of unapproved drugs.
Read the News: "FDA issues Warning Letters to multiple companies for CGMP and QSR violations"
8/18/2025
U.S. FDA Announces "Regulatory Accelerator"
A Regulatory Support System for Medical Device Developers
The U.S. Food and Drug Administration (FDA) has announced the Regulatory Accelerator, a new regulatory program designed to assist medical device developers. The program is designed to help developers of medical devices, including new technologies such as AI and telemedicine devices, comply with FDA regulations appropriately and expeditiously in the following three main components
a listing and visualization of application-related tools, guidance, and support systems available at each stage of development through post-market
meetings during the pre-application phase to provide early confirmation of product design and regulatory application direction
A tool to efficiently search and reference relevant guidance based on product characteristics
The Regulatory Accelerator is a new initiative by the FDA's Digital Health Center of Excellence (DHCoE). It aims to simplify and streamline FDA processes for developers and innovators of digital medical device software, thereby improving efficiency and transparency.
This program is expected to improve the accuracy of applications, shorten the review period, and accelerate time to market.
Reference: U.S. Food & Drug Administration Regulatory Accelerator
8/14/2025
US FDA Medical Device Facility Registration Fees for Fiscal Year 2025
The US Food and Drug Administration (FDA) requires medical device facilities to renew their registration annually.
Starting in the 2026 fiscal year, the registration fee for medical device facilities will increase from $9,280 to $11,423.
These new fees will apply to medical device facility registrations or renewals processed between 1 October 2025 and 30 September 2026.
Globizz can assist with the medical device facility registrations during this period. Please feel free to contact us for more information.
Renewal period: 1 October to 31 December 2025.
8/12/2025
FDA: Electronic Submission Template for Medical Device De Novo Requests
The U.S. Food and Drug Administration (FDA) has issued final guidance requiring the use of eSTAR (Electronic Submission Template And Resource) for all medical device de novo applications submitted on or after October 1, 2025. This action is intended to improve the quality of submissions and the efficiency of the review process.
The eSTAR system consists of applicant information, contact information, past review history, product information, non-clinical/clinical study data, and labeling (labeling and attachments).
When Does this start?
October 1, 2025
Eligibility
All domestic and foreign medical device manufacturers submitting DeNovo applications to the FDA
How to submit
electronic submission via electronic template (eSTAR)
Where to start
- 1. Download the eSTAR template from the official FDA website
- 2. Follow the instructions to enter and attach the required information
- 3. Submit through eSubmitter
8/11/2025
FDA Approves First Blood Test to Diagnose Alzheimer's Disease
On May 16, 2025, the Food and Drug Administration (FDA) approved the first in vitro diagnostic drug with a blood test to aid in the diagnosis of Alzheimer's disease.
The approved test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, developed by Fuji Levio Diagnostics, Inc., is designed for the early detection of amyloid plaques associated with Alzheimer’s disease. It is intended for use in adults aged 55 and older who are experiencing signs and symptoms of the disease. The test is performed using Fujirebio’s fully automated LUMIPULSE G1200 instrument system.
The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test received FDA Breakthrough Device designation in February 2019, was submitted for 510(k) clearance in December 2020, and was approved on May 16, 2025.
Advancement of Non-Invasive Diagnostic Methods
The diagnosis of Alzheimer's disease has traditionally relied on invasive and costly procedures, such as cerebrospinal fluid (CSF) analysis and positron emission tomography (PET) imaging. However, the recent FDA approval of a non-invasive blood-based biomarker test represents a significant paradigm shift. This milestone suggests that, going forward, regulatory evaluations may increasingly consider the trade-off between diagnostic accuracy and procedural invasiveness, potentially fostering broader adoption of non-invasive diagnostic technologies in clinical practice.
Impact on Practice and Points to Consider
The advancement of diagnostic devices based on disease-specific biomarkers is anticipated to accelerate in the coming years. For companies seeking to commercialize blood-based diagnostic tests, it will be essential to establish both their clinical validity—i.e., the extent to which the biomarker test accurately reflects the presence or progression of the disease—and their clinical utility, meaning the test’s actual effectiveness and benefit in guiding medical decision-making and improving patient outcomes. Scientific evidence supporting both aspects will be critical for regulatory approval and adoption in clinical settings.
Globizz provides comprehensive support ranging from research and development to commercialization of diagnostic devices, including assistance with FDA approval acquisition, evaluation of the validity and clinical utility of biomarkers, and formulation of market entry strategies.
If you are considering the development or global expansion of diagnostic devices, please do not hesitate to contact Globizz. Leveraging our expertise and proven track record, we offer tailored solutions to meet your needs.
Resource: U.S. Food & Drug Administration: FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease
7/31/2025
FDA Elimination of Import Exemption to the U.S.
On July 9, 2025, U.S. Customs and Border Protection (CBP) announced a significant amendment to the import review procedures for products regulated by the U.S. Food and Drug Administration (FDA). Consequently, all such products are now subject to FDA review, including small-value imports (Section 321 shipments) of $800 or less per item.
The Relationship Between Section 321 Shipments and FDA Review
Section 321 exempts shipments valued at $800 or less per item from customs duties, and is primarily used for personal imports, samples and small-lot commerce. Until now, under this system, some FDA-regulated products have been cleared through customs without FDA notification.
This operational change clarifies that even such low-priced products must be cleared by the FDA electronically before they can be imported.
Impact on Practice and Points to Consider
As a result of this operational change, the following basic requirements must be in place in advance, even for imports of small quantities and samples.
- • Product data must be consistent with the content of the application to the FDA.
- • Prior confirmation of product labels, ingredient information and registration requirements.
- • Establishment of a communication system including US agents
Even a single occurrence of incomplete documentation or misclassification may result in an import being held or denied by the FDA.
Future Responses and Support
The FDA has stated that it 'values dialogue with importers and will respond to questions', and is accepting enquiries at [email protected]. However, many situations require specialized responses in English and an accurate understanding of the system. Practical assistance based on expertise, such as import support, FDA label review, prior notice representation and product category research, will help ensure more reliable and efficient import operations. Globizz is a leading provider of import support services in the US and Canada.
Our consultants are well versed in these processes and can support you with all import procedures. Please feel free to contact us if you have any concerns about dealing with the FDA or are considering exporting to the US market in the future.
Resource: U.S. Food & Drug Administration: Notice to Industry on FDA imports review exemption change
5/28/2025
Hankook Research – Globizz Sign Comprehensive MOU to Provide Medical Device Total FDA Approval Solutions
(Right) Jae Sun Jung/ CEO, Hankook Research
（Left）Takahiro Haruyama / CEO, Globizz FDA Consulting
On the 26th, Hankook Research Co., Ltd., a leading full-service market research firm, signed a strategic Memorandum of Understanding (MOU) with Globizz, a global leader in FDA consulting, to offer comprehensive services across all areas required for FDA approval of medical devices. Through this partnership, the two organizations aim to collaborate in providing services that cover usability testing and regulatory affairs (RA) for global medical device manufacturers.
This agreement brings together the Innovation Division of Hankook Research, known for its top-tier global UX research and usability evaluation capabilities, and Globizz, which provides FDA consulting services in the U.S., Korea, Japan, India, and other countries. Their joint objective is to support not only the entry of Korean medical devices into the U.S. market but also to offer usability evaluations and regulatory services to medical device companies throughout the Asia-Pacific region.
Mr. Kang Deok-yong, Head of the Innovation Division at Hankook Research, stated,
“Our Innovation Division’s Medical Device Usability Evaluation Center possesses excellent research capabilities and international experience, which give us a strong competitive edge not only in Korea but also across the Asia-Pacific region. With this MOU, Hankook Research has established global capabilities to offer professional services across the entire lifecycle of medical device development — from the very first steps to the final stages.”
Mr. Takahiro Haruyama, CEO of Globizz, remarked,
“Through this partnership with Hankook Research’s Innovation Division, we are looking not only at the Korean market but at the Asia-Pacific region as a whole. We believe that this agreement will allow us to effectively apply our expertise and experience in regulatory affairs for medical devices companies.”
Moving forward, the two organizations plan to offer a wide range of tailored services to meet the needs of Asia-Pacific medical device companies preparing to enter the U.S. market and navigate FDA approval processes.
May 22, 2025
The Use of Unannounced Inspections at Foreign Manufacturing Facilities
FDA announced to expand the use of unannounced inspections at foreign manufacturing facilities on May 6th.
This shift, based on pilot programs in India and China, aims to eliminate the double standard of advance notice given to foreign companies. Foreign companies will undergo strict inspection without advance notice, like US companies with this change.
While unannounced inspections are standard in the US, foreign manufacturers have been given weeks to prepare, raising concerns about regulatory fairness. Despite the advanced warning which foreign companies receive, the FDA still found serious deficiencies more than twice as often than domestic inspections.
Reference: FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities | FDA
April 10, 2025
US FDA OTC Monograph User Fee Program Update
Attention all drug facilities! FDA has published the over the counter (OTC) monograph drug facility fees for fiscal year (FY) 2025. The table below shows the comparison of the OMUFA (OTC Monograph User Fee Act) rates between the year 2024 and 2025.
| Facility User Fee Rates | FY 2024 | FY 2025 |
|---|---|---|
| Monograph Drug Facility (MDF) Fee | $34,166 | $37,556 |
| Contract Manufacturing Organization (CMO) Fee | $22,777 | $25,037 |
| OMOR Fee Rates | FY 2024 | FY 2025 |
|---|---|---|
| Tier 1 | $537,471 | $559,777 |
| Tier 2 | $107,494 | $111,955 |
Reference: FDA Website
March 20, 2025
Globizz and Samsung Medical Center Signed MOU to Support Overseas Expansion of Medical Devices in South Korea
On March 20th, 2025, the global medical device regulatory consulting firm, Globizz, and the Usability Evaluation Center of the Smart Healthcare Research Institute at Samsung Medical Center signed a Memorandum of Understanding (MOU) to support domestic medical device companies in their overseas market expansion and usability evaluation. The signing ceremony was attended by Takahiro Haruyama, CEO of Globizz, and Yanghyun Cho, Director of the Usability Evaluation Center, who signed the MOU and discussed future collaboration plans.
Through this MOU, Globizz, a professional consulting firm specializing in overseas medical device regulatory approvals, will actively support domestic companies in obtaining FDA approval for their international expansion in collaboration with Samsung Medical Center.
Furthermore, Globizz plans to participate as a speaker at symposiums analyzing FDA regulatory trends and sharing insights into the latest regulatory developments.
Additionally, both organizations aim to strengthen the global competitiveness of Korea’s medical device industry by jointly planning national research projects. Details of the joint symposium and collaborative activities will be forthcoming as soon as concrete plans are in place.
This agreement is expected to serve as a significant steppingstone for domestic medical device companies in successfully entering overseas markets.
March 20-23, 2025
The 40th KIMES 2025 in Seoul
We will participate again this year in KIMES 2025, where more than 1,350 medical device companies from more than 35 countries will gather in Seoul, South Korea!
As an horner of the seminar speaker hosted by the Korea Testing Laboratory (KTL), a senior researcher, who is also a medical professional in Los Angeles, will join the seminar.
This will be a rare opportunity to ask her about FDA or US medical device questions.
Date of the Seminar: March 20, 2025
Time: 11:00 - 12:00
Seminar Location: COEX 3F conference room 328
Reservation are strongly recommended as space is limited.
February 26-27, 2025
Medical Device Event "MEDTECH SUMMIT BUDAPEST 2025"
Medtech Summit in Budapest is back!
This year's seminar has been significantly upgraded in both scale and content, and will focus not only on the European medical device market, but also on the U.S. medical device market, providing an excellent opportunity to grasp the latest trends and technological innovations in the medical device industry and to expand business opportunities.
Globizz Corp. will participate as a specialist in medical devices and U.S. market access for the U.S. FDA and will conduct a seminar.
We will also be moderating a separate conference of FDA specialists.
"MEDTECH SUMMIT BUDAPEST 2025"
We look forward to seeing people from all over the world!
January 23, 2025 (Posted by FDA: October 2, 2024)
FDA, EPA and USDA released the tool to look for the regulatory relates to the genetically modified microorganism
The U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA) have released a simple tool to help bioengineers find regulations related to genetically modified microorganisms.
This tool was developed in response to the Executive Order on biotechnology and aims to improve the transparency and efficiency of bioengineering regulations.
Users can use the tool to check relevant laws (Code of Federal Regulations) and federal agencies related to their products by selecting product-specific options.
The tool is particularly helpful for researchers, developers, and businesses working with genetically modified bioengineering in the early stages of research and development.
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
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