Medical device date management consulting
Updated: July 2025, 3
To all business owners who do business with foreign manufacturers
Do you know the renewal deadline of the foreign manufacturer you do business with?
In order to import medical devices manufactured in a foreign country and sell them in Japan, the importing company must obtain a manufacturing and sales business license and medical device manufacturing business registration. Must be registered.
However, considering that even just one product may involve several foreign manufacturers, managing all of them can be a huge burden on busy people.
To prevent company losses, ourPlease use our date management (renewal deadline management) service!
Manage foreign manufacturers and reduce risk and human resources.
What is the visa date management service?
We will create a list of businesses that you already do business with and then perform the "QMS conformity assessment" and "foreign manufacturer registration renewal" services.
QMS conformity survey
A QMS conformity survey is conducted on a manufacturer or registered manufacturer at the time of reviewing a manufacturing/sales approval application or certification application, and investigates whether proper manufacturing is being carried out in compliance with the QMS ministerial ordinance. Thing.
There is a written survey and an on-site survey at the manufacturing site.
A renewal survey is conducted every five years.
Renewal (every 5 years) Submitted materials
The documents to be submitted for renewal every five years are as follows:
| What is specified in the investigation procedure notice | 1. Copy of approval form for partial changes to approved items and minor change notification since the previous survey | |
| 13485. ISOXNUMX certificate and audit report, on-site inspection report by other inspectors conducted within the past three years from the date of application for conformity inspection of the facility to be inspected, certificate or inspection report of the other country based on MOU, etc., copy of conformity certificate from foreign authority, etc. | 〇Checkpoint〇 Submit the following required documents: 13485. ISOXNUMX certificate and audit report ② Reports of on-site inspections by foreign authorities, excluding third-party certification bodies ③Certificates or investigation reports from partner countries based on MOUs, etc. ④Certificates of conformity from foreign authorities, etc. | |
| 3. Overview of manufacturing process for surveyed items | 〇Checkpoint〇 ・All facilities can be identified from receiving component parts to shipping decisions. ・Description that shows the details of the specific work | |
| 4. Materials that can confirm the outline of activities carried out at each survey target facility and the interrelationship of the quality control and supervision systems at each survey target facility | 〇Checkpoint〇 ・About all registered manufacturing facilities ・Overview of activities | |
| 5. A summary of any recoveries since the last periodic compliance inspection. | 〇Checkpoint〇 Include the start date of recall, product name, details of recall, class classification related to recall, name of related manufacturing site, etc. | |
| 6. oath | ||
| Survey Guidelines Notification Form 4-2. (6) “Materials required by compliance survey implementer” | 1. Information on the surveyed facilities (1) Overview of the surveyed facilities (2) Layout map of surveyed facilities (3) Floor plan of the surveyed facility, list of main facilities and equipment related to manufacturing, and list of main facilities and equipment related to testing and inspection. | 〇Checkpoint〇 (XNUMX) Overview ・Manufacturers, etc., designated foreign-manufactured medical device manufacturers, etc., and all registered manufacturing facilities ・For overseas manufacturing sites, the language to fill in can be English. ・If the manufacturer, etc. and the registered manufacturing facility are the same facility, it is OK to list them together. (2) Layout plan ・All registered manufacturing facilities except design facilities ・Aerial photographs are OK for drawings. (3) Plan view ・Clearly identify manufacturing areas, clean rooms, etc. |
| 2. QMS-related materials (1) Organization chart of survey subjects (2) Quality control supervision system standards (quality manual) (3) List of management documents | ||
| 3. Materials related to the item (1) Copy of child item list (Form 3) and standard conformity certificate pertaining to the application item (2) Overview of product standards (3) Documents that provide an overview of the item, such as package inserts (4) Implementation status of validation in manufacturing process (5) Annual manufacturing and sales volume for the past three years (6) For medical devices that use biological raw materials, documents showing that they have been inspected for quality problems from the perspective of ensuring safety. | 〇Checkpoint〇 (2) Overview If multiple facilities are involved in each item, the documents, etc. from each facility shall be properly described in the product standard so that the linkage can be clearly understood. (3) If there is a process in which validation was performed for the applied item, submit a list of the process name, facility and implementation period (date of approval of final report). | |
| 3. Materials related to Chapter XNUMX of the QMS Ministerial Ordinance (1) Procedures, etc. related to reporting defects to manufacturers, etc. (2) An oath stating that the domestic quality operations manager meets the requirements. (3) Procedure manual for the work of the domestic quality operations manager (4) Written agreement with registered manufacturing facility, etc. (5) Procedures for processing notifications from repair companies and used product sellers or lenders, and ensuring quality at medical device sellers or lenders. | 〇Checkpoint〇 (3) Procedure manual ① Oversight of domestic quality control operations ②Decision on shipping to market ③ Collection of information regarding product quality, etc. (including changes that affect product quality) and reporting to managers, etc. ④ Product collection ⑤ Reporting of post-market safety information to the safety management department, etc. (4) Written agreement If the marketing authorization holder does not have a direct agreement with a registered manufacturing facility and collects information indirectly through another registered manufacturing facility, a copy of the agreement between the said registered manufacturing facility and the other registered manufacturing facility must be submitted. |
*Separate materials may be required as necessary.
Foreign manufacturer renewal procedures
A foreign manufacturer's registration must be renewed every five years or it will no longer be valid.
Regarding the application period,Apply approximately 5 months before the expiry date
The following documents must be attached to the renewal application.
- Foreign manufacturer registration certificate (original)
- Drawing showing the location of the manufacturing facility
Advantages of requesting support from an administrative scrivener corporation
At Support Administrative Scrivener Corporation, we have extensive experience in procedures related to medical devices, and our specialized staff quickly and reliably handles various applications for our customers.
①Speed compatible
Our speedy response has been praised by many customers, and we support your company's entry into the business as quickly as possible, from building an organizational structure to preparing documents and obtaining permits to start your business.
② Easy contact system
We offer free consultations.
We have offices in four locations across the country: Tokyo, Nagoya, and Osaka, and we provide nationwide service from these bases.
We also accept inquiries from overseas via the Internet.
We also have staff who can speak Chinese, English, and Korean, so we can help you even if it is difficult to consult in Japanese.
If you have any questions about medical equipment, please feel free to contact us!
③ We also provide solid support for building a compliance system.
We can create procedure manuals, etc. in a format that suits your company's actual situation while still meeting the standards.
We also have extensive experience in permit renewals and provide internal audit support.
For business operators, obtaining a permit is not a goal, but a starting point.
We will provide solid support with an eye to the future.
