Medical equipment deadline management guide
Updated: July 2024, 3
To all managers of manufacturing and commerce in foreign countries,
What is the renewal termination date for foreign manufacturing business orders that you know?
If the medical equipment manufactured outside of Japan is located in Japan, the company must be able to purchase the manufactured equipment, and the medical equipment manufacturing industry may be completed, and the overseas manufacturing facility may be operated by foreign manufacturers.
However, the company has always been responsible for the production of several foreign products, and the management of this process has been a huge burden on the company's very busy landlords.
Preventing the company from suffering unnecessary damage,Introducing our own deadline management (renewal and termination date management)!
We are able to help you manage your foreign manufacturing business, reduce your expenses, and develop your talent.
Is it deadline management service?
We have pre-registered the company's name for the company's business, and have been working on the "QMS Compatibility Test" and "Japanese" Foreign Manufacturer Order Update.
QMS compatibility test
QMS compliance is required to comply with the QMS ministerial regulations when the manufacturer applies for ratification or approval.
There are two types of tunes: Book tunes and current factory records.
First update every five years.
Renewal (every 5 years) Requirements and exchange fees
Fees must be submitted upon renewal every five years.
Specified content of the notification list | 1. Partial change ratification of ratification and revision of partial change proposal since self-registration | |
Two.ISO13485 ISO13485 Certification and accounting report, monitoring system and other monitoring equipment, application date of application within 3 years, standard MOU's confirmation book or report on country etc. Confirmation of compatibility with foreign exchange parts | 〇Key points〇 Required submission of documents below ①ISO13485 ISO13485 certification book and accounting report ②Excludes third-party certification, external, foreign, etc. entrance equipment location notification ③MOU Basic MOU, etc., confirmation book or report on the origin of the country, etc. 4Compatibility certification book for foreign partners | |
3. Outline of the manufacturing process for controlled products | 〇Key points〇 ・Ensure that the contact parts, etc. are available. ・Explanation of specific work related to the development of the concept | |
4. A summary of the internal operational activities of each program, as well as confirmation of the performance of each program, as well as detailed information on the quality management system for each program. | 〇Key points〇 ・Manufacturer owned by Chiang Kai ・Active overview | |
5. Since my next regular meeting, I have been invited to the meeting, and the story is as follows. | 〇Key points〇 Required information: Start time of the recall, product name, content of the recall, division of the recall, formation of the manufacturing facility in relation to the recall, etc. | |
6. oath book | ||
Table 4, 2. (6) “Materials required by the program provider” | 1. Fees for provision of training and assistance (1) Outline of the program to be monitored (2) Tracked design layout (3) After the design of the plane screen, the main design of the production system, and the main design of the main design of the production system, the main design of the main design and design of the game can be cleaned. | 〇Key points〇 (1) Overview ・Manufacturers, etc., designated foreign manufacturers of medical equipment, etc., and owned manufacturing facilities ・English copy for the overseas factory. ・Manufacturers, etc. may be located in the same facility, and may be listed in multiple locations. (2) Cloth Bureau Encyclopedia ・Complete production facility excluding design ・Can be used as a plane display (3) Plane image ・Myongjeong manufacturing area, Washing room, etc. |
Two.QMS Provided QMS fees (1) Structure of the examinee (2) Standard document for quality management system (quality manual) (3) Management document clarity | ||
3. Materials for the gift category (1) Subsidiary item classification (table case 3) and certification of the certification of the application and certification. (2) General description of product specifications (3) Articles summarizing the progress of the purchased items, appendixes, etc. (4) Confirmation of effectiveness during the manufacturing process (5) Annual income and song volume for the past three years (6) Use of biological raw materials for medical equipment, etc., for safe use, and for materials with quality problems. | 〇Key points〇 (2) Overview (3) If the product category has been approved, please submit the following information: name of the order, time of approval of the order (last reported date of ratification). | |
Four.QMS Ministerial Ordinance No. 3 Chapter's qualifications (1) Procedures for quality control procedures, etc. for customers in the manufacturing industry and for failure situations. (2) Declaration of Domestic Quality Operations and Compliance with Responsible Persons (3) Domestic product quality management procedures for personnel responsible for managing domestic product quality operations (4) References to Yojuku Manufacturing Co., Ltd. (5) Procedures for notifying medical repair operators and second-hand goods sellers or buyers, and procedures for providing quality guarantee for medical equipment sellers or buyers. | 〇Key points〇 (3) Quality control procedure ① Japanese quality management practices ②Determination of market quality ③ Information regarding the quality of collected products (comprehensive product quality changes, etc.) and reporting by the person in charge of management, etc. ④ Goods recall ⑤ Report to safety management department regarding safety information after product launch (4) Book reading If you are a manufacturer of products, please contact the manufacturer directly, and if you have any questions, please contact the manufacturer directly. |
*If necessary, also possible demand provision and other fees.
Renewal instructions for foreign manufacturers
The first renewal process has been removed every five years, and the foreign manufacturer has failed to issue an official notice.
The application is hereSubmit five months before the effective date.
Renewal application must be submitted with the following documents.
- Foreign manufacturing industry certification (original case)
- Locational map of Showji Manufacturing Co., Ltd.
Why Choose Us
We have medical equipment available in each category, and our employees can quickly report various types of procedures to local representatives.
①Quick delivery
We have achieved a high speed flight and have achieved a high altitude record. We will provide you with the complete construction, production materials, support services, and support services for each category of the industry after we have started.
②Learning method
We provide free shipping charge.
We are located in Tokyo (Shinjuku and Akihabara), Nagoya and Osaka, and from now on, we are based here and cover all of Japan.
We can provide you with a mutual telephone service for international shipping.
I am also a member of the staff who can write Chinese, English and Japanese texts. Therefore, if you have any difficulty in reading the Japanese language for immediate use, we will also provide the language for you.
If you have any questions about our medical equipment, please call us!
③ Provide strong support for building an integrated system
We may also copy the actual information of the joint purchase company or the quality management procedures of the joint stock company and other documents.
If you have any questions about the update, we can also support you by providing internal accounting.
From here on, the company will be able to obtain it, it will be the last point, and it will be the beginning.
We look forward to providing you with future support services.
