Medical device regulatory applications.
total support
Smooth application to PMDA and certification bodies.
Regulatory compliance professionals are available to assist you.
Leave it to MedRegi MedRegi to file regulatory applications for medical devices.
- We provide total support for medical device regulatory applications.
- Smooth regulatory applications to PMDA and certification bodies.
In order to manufacture and sell medical devices in Japan, it is essential to make appropriate applications to the PMDA and certification bodies. es-pacio provides consulting services for each application phase to help ensure smooth approval.
application and service
Details of each application and service
PMDA Application Procedures
Classification of medical devices
Support for certification and conformity to PMDA
Support for conformance testing
Preparation of application documents
Review
ISO Certification Body Procedures
Certification and Conformity Assistance
Support for ISO13485 acquisition
GVP and QMS compliance support
Supports electrical safety and EMC testing
Other Support
Sales Strategy Consulting
Regulatory compliance for overseas markets
Follow-up after approval/certification (renewal application, quality control support)
Application Service Flow
Application Service Flow
Step 1
Preliminary research and strategic planning
(Market research, etc.)
(Classification confirmation)
Step 2
Preparation of necessary documents
(Conformity survey documents and
(QMS compliance)
Step 3
Negotiation with PMDA and certification bodies
(Additional materials supported)
(Q&A)
Step 4
Approval obtained
Strengths of MedRegi Application
Strengths of MedRegi Application
- Experienced Regulatory Consultant (over 20 years of consulting experience specializing in medical devices)
- High success rate of applications (cumulative total of more than 30 applications supported)
- Ability to negotiate with PMDA and certification bodies
- Quick response and generous support
FAQ
Frequently Asked Questions
How long does a PMDA application take?
Although it varies depending on the nature of the application and the class classification of the medical device, MedRegi generally takes 6 to 18 months to apply for approval with the PMDA.
Since the time frame may vary depending on the progress of preliminary consultation and screening, early preparation is recommended.
What is the difference between proceeding with a regulatory application in-house?
If we proceed in-house, we will need to check the application requirements, prepare the documents, and deal with the PMDA all in-house.
MedReji reduces the burden of the application process with the support of our expert regulatory affairs consultants.
In addition, we can propose appropriate application strategies based on the latest regulatory information, leading to smooth progress in the examination process.
Can you also support ISO 13485 certification?
MedReji also provides assistance in obtaining ISO 13485 certification.
We provide comprehensive support for the establishment of quality management systems, internal audits, and certification audits.
Please feel free to contact us to discuss the best acquisition plan for your company's current situation.
About Us
About Us
| service name | MedRegi |
| operating company | ES-PACIO Co. |
| representative director (i.e. someone chosen by the board of directors from among the directors to actually represent the company) | Takuma Nishioka |
| Tokyo Head Office | konindo bldg. 2-14-10 Yayoicho, Nakano-ku, Tokyo |
| capital stock | 9,000,000 yen |
| Business | Support for importation of pharmaceuticals and medical devices, and application for pharmaceutical applications on behalf of our clients Import, export, sale and lease of medical equipment, medical devices and pharmaceuticals Planning, development, manufacturing and sales of beauty equipment, beauty products, cosmetics and supplements Support for procurement of medical equipment and supplies Upkeep, maintenance, and upkeep of medical equipment at clinics |
| Main Clients | Nationwide medical institutions and laboratories Medical device manufacturer pharmaceutical manufacturer Medical equipment dealer Each system vendor |
| Licenses | Sales and lending of controlled medical devices, etc. Type 1 medical device manufacturing and sales business 13B1X10459 Manufacture of medical devices 13BZ201949 |
Contact Us
Contact Us
MedRegi provides regulatory affairs services to
Lump-sum support
Complete Regulatory Solutions with "MedRegi
All Your Regulatory Needs Handled Under One Roo
We undertake all tasks from regulatory application to certification support for medical devices, pharmaceuticals, and programmed medical devices in a single package.
Our expert team will respond quickly and reliably to your company's needs.
online interviews
Correspondence from online interviews
MedRegi provides consultation services for medical device regulatory applications through online interviews.
Our team of experts, who are well versed in applications to PMDA and certification bodies, will support your company's smooth application by providing detailed explanations of the application process and necessary items.
First, please contact us in an online interview to discuss your concerns and requests regarding the application.
We provide appropriate advice based on the latest trends in the industry.
support
Support for approval, licensing, and certification of medical devices and pharmaceuticals
We can provide approval, licensing, and certification for the actual use of developed medical devices and drugs, both new and generic. We also have extensive experience in programmed medical device applications.
medical equipment
We support procedures for approval applications, certification applications, and notifications according to the classifications of medical devices.
We provide consistent support from coordination with PMDA and third-party certification bodies to handling technical documentation (STED) and GMP conformity surveys.
Contents of response
-
Confirmation of Classification
-
Development of application strategies
-
Preparation and review of required documents
-
PMDA consultation and review support
Medical supplies
We provide support for new drug, generic and OTC drug approval applications and conformity studies.
We provide total support from development planning to preparation of CTD (Common Technical Document) and negotiation with PMDA.
Contents of response
-
Formulate development strategies
-
Creation and review of CTD
-
GCP, GMP, GLP compliance
-
PMDA Consultation and Application Procedures
Programmed Medical Devices
We support regulatory filings for programmed medical devices (SaMD) such as AI diagnostic software and health management applications.
Address software-specific requirements such as prior consultation with PMDA, addressing cybersecurity requirements, and determining appropriate classifications.
Contents of response
-
Confirmation of classifications and conformity standards
-
PMDA pre-consultation and application support
-
Cyber Security and AI Regulatory Compliance
-
QMS (Quality Management System) establishment
Obtained approval
Obtained approval for programmed medical devices
Under the Pharmaceuticals and Medical Devices Law, which went into effect on November 25, 2014, stand-alone programs (software) for the purpose of diagnosis and treatment of diseases, etc., are now regulated as medical devices. As a result, many programmed medical devices have been developed and are undergoing manufacturing and marketing approval.
We provide support for regulatory filings for these programmed medical devices and assist in obtaining smooth approvals.
Main Features
Main Features
MedRegi MedRegi provides comprehensive support for all operations from regulatory filings to certification support for medical devices, pharmaceuticals, and programmed medical devices.
Our expert team will respond quickly and reliably to your company's needs.
We will propose the best application strategy for your product.
Seamless Integration
MedRegi provides seamless support for regulatory filings. Our expert team handles everything from class classification confirmation to PMDA compliance and ISO13485 acquisition support. We facilitate the complex process of application and accelerate your company's entry into the market.
Easy to use
MedRegi handles the process from an online interview, so you can feel free to consult with us even if you do not have any technical knowledge. Our team of professionals will support you through the complexities of regulatory filings, so you can proceed with your application one issue at a time.
Cross Compatibility
MedRegi provides ongoing support after the submission of an original or generic drug application, including updates and conformity studies. We provide optimal support for change applications and additional data submissions, taking into account mutual compatibility.
Scalable
MedRegi is flexible and scalable to accommodate changes in application operations and new projects. It smoothly provides support as needed in the areas of medical devices, pharmaceuticals, and programmed medical devices.
Secure
MedRegi properly manages clients' confidential information through advanced security measures and a strict confidentiality system. You can use MedRegi with peace of mind through its highly reliable operation in a secure environment for application work.
Cost Effective
MedRegi provides high quality pharmaceutical application support at a fair price. We offer one of the most affordable fees in the industry, ensuring a smooth and cost-effective application process. We also offer flexible plans that allow you to select only the support you need.