2024.4.8

announcement

We will exhibit at "Medtec Japan 2024"
We will be exhibiting at "Medtec Japan 2024," an exhibition related to the manufacturing and design of medical devices, to be held at Tokyo Big Sight from Wednesday, April 17th to Friday, April 19th, 2024.
(We will be exhibiting jointly with our group company Demer Medical Japan Co., Ltd.)

Exhibition booth East 2 hall NO.3605
If you have any problems regarding pharmaceutical procedures, please feel free to contact us.
Please stop by if you are visiting.

*Pre-registration for MedtecJapan2024 is required when visiting.
Visitor registration

2024.1.26

announcement

Exhibition at "Medtec Japan 2024"

We are pleased to announce our participation in the "Medtec Japan 2024" exhibition, dedicated to the manufacturing and design of medical devices.
The event will take place at Tokyo Big Sight from April 17th (Wednesday) to 19th (Friday).
(We will be exhibiting jointly with our affiliated company, D-MAH Medical Japan Co., Ltd.)
Further details will be provided as soon as they are confirmed.

2024.1.4

announcement

New Year Greetings

Wishing you a Happy New Year!
We extend our heartfelt gratitude for your continued support.

Your considerable efforts throughout the past year have not gone unnoticed, and we express our sincere appreciation.
As we embark on 2024, we respectfully seek your ongoing support and favor.

We anticipate another year of fruitful collaboration.

2023.12.19

announcement

New Year’s holiday

Our company will be in winter recess between Dec.29 and Jan.3.
Thank you for all your kind support of this year and continuous help for new year.

2023.11.20

announcement

Notice of Company Name Change and Office Relocation

We would like to inform you that, due to business expansion, our head office will be relocating to the following address. We kindly ask for your continued support in the future.

▪ Moving Date : December 1, 2023
▪ New Address :
〒103-0001, Tokyo, Chuo-ku, Nihonbashi Kodenmacho 14-7, Axa Kodenmacho Building 7F

If you happen to be in the vicinity, please feel free to drop by.
Please note that there are no changes to our phone number.

2023.10.18

announcement

Notice of business partnership

2023.10.4

announcement

Due to reaching full capacity, we have closed registration.
We are pleased to announce the upcoming "Introduction to Medical Device QMS Seminar in Osaka" scheduled for November! This seminar is intended for individuals involved in regulatory affairs and quality management in newly entering companies, manufacturing and sales, and manufacturing industries.
As we approach the final stages of the transition period for the revised QMS regulations, this seminar will cover fundamental concepts of QMS, various required tasks, usability, cybersecurity measures, and common fi ndings in QMS compliance inspections.

【Event Overview 】
■ Date:
November 17, 2023 (Friday) 10:00 AM - 4:00 PM

■ Venue:
Doon Center (Osaka Prefectural Men and Women's Equal Participation and Youth Center) Middle Conference Room 3
Nearest Stations: Keihan "Temmabashi" Station, Osaka Metro (Former Osaka Municipal Subway) Tanimachi Line "Temmabashi" Station

■ Participation Fee:
¥9,000 per person (excluding tax)
Please note that the number of participants is limited, so we encourage you to register early.

2023.10.3

announcement

We will be exhibiting at the "14th Healthcare and Medical Device
Development Exhibition" (Intex Osaka) from October 4th (Wednesday) to 6th (Friday).This exhibition showcases the development and manufacturing technologies of medical and healthcare devices.
(We will be jointly exhibiting with our group company, EPJ Medical Services Co., Ltd.)

Exhibition Booth: Building 6 (Hall A), Booth No. 37-7
If you have any concerns or questions about pharmaceutical procedures,
please feel free to consult with us. We look forward to your visit.

※ When visiting, we kindly ask you to register in advance (free of charge).
[Link to Pre registration]
https://www.manufacturing-orld.jp/kansai/en/about/medix.html

2023.9.1

announcement

We would like to inform you that the following officers have been appointed as of September 1, 2023.
Appointment date: September 1, 2023
Masahiko Tomita Vice President Executive Officer (MAHO business management)

2023.8.21

announcement

We pleased to announce that on September 5th of this year, we will be celebrating our 22nd anniversary since our company`s establishment. We sincerely express our deepest gratitude for the warm support and kindness extended to us by all.

Please note that on September 5th (Tuesday), in commemoration of the group's establishment anniversary, all of our offices will be closed.

We kindly ask for your continued support and patronage in the years to come.

Thank you for your consideration.

2023.4.13

announcement

Notice of Participation in “Medtec Japan 2023”
We will be exhibiting at "Medtec Japan 2023", an exhibition related to the manufacturing and design of medical devices, to be held at Tokyo Big Sight from Wednesday, April 19th to Friday, April 22nd, 2023.
(We will be exhibiting jointly with our group company Expartner Japan Co., Ltd.)

Exhibition Booth No. 2700
We would like to introduce you to the Marketing Authorization Holder services (MAH), the Designated Marketing Authorization Holder services (DMAH), and our medical device logistics services.
*Pre-registration for Medtec Japan2023 is required when visiting.
https://www.medtecjapanreg.com/2023/form.cgi?lang=ja

We look forward to seeing you at the event.

2023.3.23

announcement

We have opened a satellite room near our head office as a place for consultation and interaction with regulatory personnel.

2022.12.20

announcement

Notice of year-end and New Year business hours
We will be closed from December 30, 2022 to January 3, 2023.
We will resume normal business hours from January 4th.
Thank you very much for your help this year.
We look forward to your continued support in 2023.

2022.10.27

announcement

We made a PR for our company.
⇒Click here to watch the movie.

2022.10.14

announcement

Business results have been updated.

2022.8.19

announcement

Announcement of the "Regulatory Affairs School, New Employee Program 2023"
We are pleased to inform you that a regulatory affairs seminar will be held exclusively for new employees and newly appointed personnel scheduled to be assigned to the regulatory affairs department in the coming fiscal year.
This seminar is designed to serve as training for new employees (both recent graduates and those with prior work experience) and those who have received job offers.

The training is scheduled to take place in February to March 2023 and will be conducted through both online (WEB) and on site formats.

Detailed information about the event will be provided after September. If your company is interested, please inquire through the form below. We will notify you as soon as the details are confirmed.

Request for Information on the "Regulatory Affairs School New Employee Program 2023"

2022.8.12

announcement

Notice of Our Group's 22nd Anniversary and Closure

We sincerely apologize for any inconvenience. On September 5, 2022 (Monday), our group company, Expartner Japan Co., Ltd., will observe its establishment anniversary, and consequently, all offices will be temporarily closed.
We appreciate your understanding and cooperation during this time.

2022.8.1

announcement

Notice Regarding Regulatory Support Services

In response to the frequent inquiries about the process from business entrustment to approval in the application support services, we have prepared an easy-to-understand flowchart. Please make use of it.
Please note that this is just one example, and for more detailed information, feel free to contact us.

2022.7.26

announcement

Due to popular demand, we have decided to hold another session in August!!!
The consultation event held in July concluded successfully, thanks to the participation of all attendees. We are pleased to announce that due to its overwhelming popularity, we have decided to hold another session in August.
Notice of Regulatory Consultation (Free of Charge)!!
We are conducting free consultation sessions for companies facing challenges in the regulatory procedures for medical devices. The sessions will be held on the following dates:
(Method: Either at our office or through a web meeting system such as Zoom or Webex. A confidentiality agreement will be presented in advance for your peace of mind.)
Examples of topics you may consult on:
・Guidance on the necessary business permits and procedures for entering the medical device industry.
・Understanding the standards and tests required for the application and notification of medical devices.
・Information on the time and costs required for the market launch of medical devices.
・Checking the regulatory documents held by your company.
・Seeking advice on approaching PMDA and certification bodies.
・Taking over the preparation of incomplete regulatory documents or interrupted applications.
・Assistance with responding to inquiries during the examination process.
・Verification of alignment between application documents and supporting evidence.
・Looking for companies that can act as a Designated Marketing Authorization Holder (DMAH) or a Medical Device Authorization Holder (MAH).

Feel free to consult on any regulatory challenges you may be facing.
Dates:
- August 3rd (Wednesday)
- August 5th (Friday)
- August 17th (Wednesday)
- August 19th (Friday)
 ⇒ Session 1: 10:00 AM 11:00 AM
 ⇒ Session 2: 2:00 PM 3:00 PM
 ⇒ Session 3: 4:00 PM 5:00 PM

2022.4.15

announcement

Notice of Estimate Request Form
We are pleased to introduce a simple estimate request form for your convenience. When requesting services such as product application procedures, QMS services, or permission/registration applications, please feel free to utilize this form.

2021.8.24

announcement

20th Anniversary Greetings
We are delighted to announce that our company will be celebrating its 20th anniversary on September 5, 2021. We express our sincere gratitude to the numerous medical device companies, stakeholders, and our dedicated staff who have supported us throughout t his significant journey.

Since our establishment, we have consistently operated as a regulatory consulting firm specializing in medical devices. Our commitment remains steadfast: "To deliver better medical devices to healthcare professionals as soon as possible." Our entire team i s dedicated to providing enhanced services for your benefit.

We sincerely appreciate your ongoing support and patronage.

Expert Partner Japan Co., Ltd.
Hideki Fujitsuka
President and CEO

2021.5.11

announcement

The latest version of the quality manual that complies with the QMS ministerial ordinance revised in March of this year is now on sale!!
Click here for details.

2020.12.2

announcement

We have commenced consulting services on regulatory affairs compliance based on the amendments to the Pharmaceutical and Medical Device Act by Law No. 63.

2020.11.27

announcement

In-house Training Instructor Dispatch Service
We offer instructor dispatch services for in-house training on pharmaceutical and medical device laws, specifically tailored for companies entering the medical device industry. We can flexibly accommodate your company's specific needs with topics related to pharmaceutical and medical device regulations.

2020.11.27

announcement

QMS/ISO Audit Services
For companies planning medical device QMS compliance assessments or ISO 13485 certification audits, we offer a service to check the current compliance status in advance and dispatch auditors to provide advice.

2019.02.01

announcement

”Achievements” updated

2016.05.13

announcement

On May 13th EPJ launched it's 2016 Regulatory Affairs School in Tokyo.
Now in its 12th year, EPJ conducts the seminars for employees of Japanese medical device manufactures who aim to become a Regulatory Affairs Specialist.