Guanyu New demand-oriented engineering Japanese medical equipment
Different process, different design, different emotional notes
Currently available or approved manufacturer's rules
Currently available in the manufacturing facility, the demand for changes in the manufacturing facility is monitored, the renewal date is the same as the deadline in advance.
Manufacturers and suppliers will be required to submit new demand for existing product exchanges, etc. within three months after the effective date of the amendments to the Demand Act (November 26, 11).
However, if you check the factory, you will be able to check the factory, and there will be no demand for new instructions.
Comparison of product manufacturing sales, manufacturing industry, sales, product purpose approval and approval
The basis of the law, the use of medical equipment in the country, only the case part is inserted, the case part (the case) itself is not accepted, the original state of the case is not correct, but after the law has been revised, the German case body is also completed. Fantastic The elephant.
The company has acquired the first or second type of medical equipment manufacturing business, and has acquired the first or second type of medical equipment manufacturing based on demand, highly managed medical equipment, and other medical equipment.
Based on the basic use of the medical equipment category, it is also possible to approve or approve the purpose of the product in Germany.
We provide communication services for medical equipment and monitor the sales of medical equipment.
How to provide high-level management of medical equipment through electronic communication, and how to obtain demand for medical equipment, and how to provide management of medical equipment, and how to obtain and manage demand for medical equipment.
Revised supplementary literature
The application was made on November 26, 11, and the medical equipment was approved before November 25, 11. Guidance training appendix Literature.
We are a medical equipment manufacturing and music enterprise that provides medical equipment, etc., and is responsible for supporting the amendments to the accompanying documents and providing guidance.
Additional notes for notes
After the enforcement of the Medical Instruments Act
Construction or modification date
This is the year, month, and year of the Japanese version of this edition. At the time of revision, it provides a clear revision history, ensuring continuity.
Approval number etc.
The name of the exclusion is ``prohibited reuse'', the name of the name is ``prohibited reuse'', and the name of the ``prohibited reuse'' is outside the name of the plan.
Classification and general name, etc.
Publication No. 298 of the Ministry of Health, Labor and Welfare, as specified by JMDN, and its subsequent classifications (highly managed medical equipment, managed medical equipment, general medical equipment; specified insurance managed medical equipment, set-up managed medical equipment). For any other reason, if you agree to use the general name of the medical device, please note that under various circumstances, please read the following. Acknowledgment General name for books.
Purchase name
应记载贩卖Name. Unnecessary record names, honorific titles, etc. Guided users may be aware of different product names that may be mixed in production over time.
caveat
If you have any questions about medical equipment use, please be aware of the special dangers that may occur. The current situation (patient), the medical equipment used in conjunction with the instructions for use, and the warnings related to the use of the equipment are detailed in this article.
Contraindication/prohibition
躔记载该设计设计设计设计设计计计过访访或应认认过设论论论记围的对围和对于设计设计设计设计或访问设计论论论记载该设夗设备设备设计设计进行设备或开应用等。 躔记载该设计设计设计设计设计strictive或开时间等或进行范围的对围和使用方法。 There are "application conditions (patients)", "combined use of medical equipment" and "methods of use", contraindications and prohibitions in various areas, and detailed information about the progress of the medical equipment.
Shape, structure, principle, etc.
Please read the instructions for understanding the general structure of the medical equipment, the basics, the exhibition catalog, the display panel, the raw materials, the parts, etc., and the basics of the functional principles of the machine.
Purpose of use or effect
The purpose or effect of the use is to obtain approval or approval. In addition, the medical equipment that we have planned, the general name of the equipment, and the progress of the various types of equipment that have been announced.
Item grade etc.
Item removal
How to use etc.
躔记载设备方法、结构方法和使用方法. Under the circumstances of the combined use of medical equipment, the requirements for medical equipment can be summarized as follows.
Precautions for use
General precautions when preparing medical equipment for use. Current situation (patient), medical equipment used in combination, instructions for use, precautions, and detailed information about the progress of this article.
The completion of the bed
If you have any questions, please confirm the following information, or if you would like to confirm the use of the product.
Storage method and effective period, etc.
The storage method and effective period for obtaining approval or approval. In addition, the expiry date or expiration date of the medical device, and the expiration date and the expiration date are set. In addition, please note the terms and conditions for purchase and storage.
Precautions for use
Please be careful when reading the special instructions for use when reading the following notes.
Safeguarding event
In this case, specific maintenance management medical equipment and multi-use medical equipment, information on where to use the equipment, the number of items required, the number of items and the number of items, etc. In this article, we will introduce the multi-use medical equipment, the cleanliness of the information, and the disinfection and sterilization methods.
Conditions of approval
As a result, there are additional conditions for approval.
包装
Delete item
Main literature and literature collection
躔记载载获取对对对应的surnames、电话等
Manufacturer's surname or name, etc.
The name or name of the elective system manufacturer (inclusive selection system manufacturer). If the manufacturer is a foreign manufacturer, the name of the manufacturer is the name of the manufacturer, or the country's name is the English name of the Japanese manufacturer.
old book law
Construction or modification date
This is the year, month, and year of the Japanese version of this edition. At the time of revision, it provides a clear revision history, ensuring continuity.
Approval number etc.
The name of the exclusion is ``prohibited reuse'', the name of the name is ``prohibited reuse'', and the name of the ``prohibited reuse'' is outside the name of the plan.
Classification and general name, etc.
Publication No. 298 of the Ministry of Health, Labor and Welfare of Demand Management, General name of designated medical equipment, JMDN, and other categories (highly managed medical equipment, managed medical equipment, general medical equipment; specified insurance managed medical equipment, equipment managed medical equipment; specified biological products, biological products). For any other reason, if you agree to use the general name of the medical device, please note that under various circumstances, please read the following. Acknowledgment General name for books.
Purchase name
应记载贩卖Name. Unnecessary record names, honorific titles, etc. Guided users may be aware of other product names that may be mixed in production over time. As a result, if you are using a specific biologically derived product, please refer to the following information for a specific biologically derived product.
caveat
If you have any questions about medical equipment use, please be aware of the special dangers that may occur. The current situation (patient), the medical equipment used in conjunction with the instructions for use, and the warnings related to the use of the equipment are detailed in this article.
Contraindication/prohibition
躔记载该设计设计设计设计设计计计过访访或应认认过设论论论记围的对围和对于设计设计设计设计或访问设计论论论记载该设夗设备设备设计设计进行设备或开应用等。 躔记载该设计设计设计设计设计strictive或开时间等或进行范围的对围和使用方法。 There are "application conditions (patients)", "combined use of medical equipment" and "methods of use", contraindications and prohibitions in various areas, and detailed information about the progress of the medical equipment.
Shape, structure, principle, etc.
For your convenience, please understand the progress of the medical equipment construction, construction guide, construction formula, construction metal components, etc.并且、应简实地记载该机器发挥 Functional principles Japanese machinery.
Purpose of use or effect
The purpose or effect of the use is to obtain approval. The purpose of use, effectiveness, and effectiveness of the medical equipment is confirmed. Definition of the general name of the medical equipment for the design of the medical equipment, the general name for the classification of the equipment and its use (Reference: July 16, 7, Notification No. 20 by the Chief of Pharmaceutical and Food Safety Bureau).
Item grade etc.
The list of items listed in the list of notes, notes, and plans is given in the notes given below.
How to operate or use etc.
躔记载设备方法、结构方法和使用方法. Under the circumstances of the combined use of medical equipment, the requirements for medical equipment can be summarized as follows.
Precautions for use
General precautions when preparing medical equipment for use. Current situation (patient), medical equipment used in combination, instructions for use, precautions, and detailed information about the progress of this article.
The completion of the bed
The results of the review or the results of the trial after production.
Inspection or storage method, usage period, etc.
General format, storage method, usage period (for each use), effective period or usage period (medical equipment with demand-specified lifespan).
Precautions for use
Please note the special specifications in the standard or approval book, the certification book, or the plan for use.
Safeguarding event
Special maintenance management medical equipment and multi-use medical equipment, record of re-use facilities, necessary measures for demand (burning bacteria, disinfection management, protection, etc.)
Conditions of approval
Conditions for additional approval exist.
包装
First name packaging
Main literature and literature collection
躔记载文获取对对子的surname or name, address, etc.
Manufacturer's surname or name, address, etc.
The name, address, and telephone number of the record-setting system manufacturer (inclusive selection system manufacturer).并且，躔记载设备设备的名字或名、应记载设备设备的medical instruments、躔记载应记载设备的国名、应记载设备的英文名。
Source of quotation: 《Review of the supplementary text of the medical equipment of Guanyu》 “(March 17, 3 药食发No. 10) day药食发0310003No.2014)
Preparation of approval, certification, and notification information for existing medical devices
As of November 2014th, 11, the manufacturer of the medical equipment, the original method of manufacturing the medical equipment, etc., and the manufacturing method of the manufacturer of the product should be changed. The reason for this is that the demand is adjusted accordingly. Contents of the record.
Our medical equipment manufacturing business is responsible for providing a series of services for medical equipment, etc., and for the management and adjustment of the system.
November 26: Medical equipment, etc. law enforcement office led to record and adjust methods and deadlines for submission.
Regulatory method
The way of adjusting the record is to change the way of changing the plan, and the way of production is according to the way of adjusting the production of the product.
Form 63-10(1): Medical equipment manufacturing approval matters minor changes modification plan book
Form 63-24(1): Foreign-manufactured medical equipment manufacturing defect booklet.
Form 66 (1): Designated highly managed medical equipment or designated managed medical equipment approval matter minor change modification plan book
Type 66 (3): Foreign-manufactured designated highly controlled medical equipment or designated managed medical equipment approval matter minor change modification plan book
Form 40: Medical products/in vitro diagnostic medical products/non-medical products/chemical products/medical equipment manufacturing and replacement plans
Submission of planning arrangements
The proposal is submitted, the approved item is approved by the director of the Independent Administrative Agency Medical Equipment Association, the approved item is approved by the independent administrative agency, and each item is requested by the independent administrative agency.
deadline for adjustment
When the amended law is implemented, among the items held by manufacturers, the new basic law shall be subject to Article 23, Section 2, Section 5, Section 6, Section 23, Section 2 of Article 23, Section 3. 、The product is manufactured by the manufacturer within 30 days of the remaining period of the longest-term product purpose.
Immediately before the deadline for setting up the records, the QMS items under the new law will be set up, and the items will be tracked and tracked in a comprehensive manner.
In addition, before the deadline for the adjustment, if there is a partial change approval (authorization) for the proposed manufacturing method, or for the purpose of manufacturing the product, the approval (authorization) for the partial change will be changed, When changing demand Completion of the task of adjusting the track record.
Before the implementation of the amended law, medical equipment in the category of medical equipment, items that were planned to be manufactured in advance of the implementation of the amended law, only the manufacturing method or the purpose of manufacturing the product were changed, and there was no demand for the new law. However, as a result, the change in the number of eyelids has changed, and the current record has been adjusted accordingly.
Licensed medical equipment, approval, approval, etc. are compatible with each other, and we are familiar with the system.
We support and submit legal claims for newly introduced medical equipment businesses, existing manufacturing businesses, production businesses, Japanese machinery businesses, etc.
Medical equipment has a high level of industry, and its capabilities are perfect, as well as small administrative staff.
However, we provide medical equipment, medical equipment, legal services, and other legal services based on the basis of our production, business, and business agents.
Our teams are present in all prefectures across the country. You must receive additional information from our system.
An all-Japan project involving staff and personnel.
