management medical equipment certification
Updated: July 2024, 3
If you have medical equipment in Japan, you must obtain approval from PMDA for the medical equipment assembly.
In terms of medical equipment approval, we have received a part of the 2nd class of 3rd class equipment, and the request for "medical equipment approval" has been filed, and we have received the medical equipment approval number.
The medical equipment is not authorized to be used as a medical equipment. Please confirm the name and other matters.
We are responsible for the management of medical equipment in the market, and provide support for our own enterprises.
Medical equipment certification process
| step 1 | Separate information on medical equipment affiliations and complaints | If you are planning to introduce medical equipment in the market, please check the medical equipment in category II and three categories. |
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| step 2 | Certification criteria | If you have any medical equipment that you would like to use, please confirm that your medical equipment is fully qualified. Please confirm that the main requirements are JIS industrial standards, and confirm that the medical equipment meets the requirements for each item. Confirmation method comprehensive commission, external test machine configuration, voluntary test, or foreign test report to confirm whether or not it conforms to JIS industrial standards, etc. |
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| step 3 | JIS industrial standard compliant test implementation | As a result, if a person runs an independent test or reports an overseas test, he or she may not be able to use the law in Japan. As a result, the medical equipment will be used every step of the way, and the equipment will be reported. |
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| step 4 | Medical equipment certification book and its production | Report on the production of medical equipment and equipment. Both parts of the application form are included, and additional fees are included in the name of the application form and STED. STED inclusion code JIS industrial standard standard 检测报报書, etc., the amount of this document is huge. |
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| step 5 | Submission of medical equipment certification book | Please send me the confirmation letter for the transaction. However, the method of acceptance is different depending on the method of acceptance, so please proceed in advance if necessary. |
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| step 6 | QMS compatibility test | During the course of the review, we will continue to monitor QMS compliance. Young people's head report, the third day of demand and accounting period. We are ready to make important progress in the area of demand design and development. |
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| step 7 | Medical equipment certification book | After confirming the name of the medical equipment, we can start manufacturing the medical equipment. |
Manufacture of medical equipment under the jurisdiction of managed medical equipment (Class II)
If you have approved the manufacturing of the medical equipment, please provide the third party approval for the production of the medical equipment.
In addition, we will ensure that medical equipment located at home or abroad is established in accordance with the QMS ministerial regulations management system, and when the application is confirmed, the demand will be met at the same time.
Designated management medical equipment manufacturing costs
| Manufacture booklet | [Book registration ceremony] Designated (advanced) controlled medical equipment Manufacture price approval certificate: 64(1). Foreign Manufactured Designated (Advanced) Controlled Medical Equipment Manufacturer's Manual: Certification No. 64(3). [Notification of preparation] Please note the following when creating a medical equipment manufacturing order (1120 No. 4) 关于medical equipment manufacturing sales booklet (药食发1120No.8) |
| Attached document (draft) | [Notification of preparation] Editing of the accompanying text of medical equipment (editing book 1002 No. 8) 关于medical equipment annexed text copy (细则) (药食安发1002No.1) 关于 MEDICAL EQUIPMENT ATTACHED MATTER EDIT PLATFORM QUESTIONS (Applications dated October 26, 10) |
| Article 23-2-23 Subsection 1: Qualified provisions for the Minister of Health and Welfare | [Fee details] Qualification for medical equipment Information on the purpose of use or effectiveness of the medical equipment References to Japanese Industrial Standards and International Electrical Instruments Associations Current medical equipment provided with different explanations [Notice of preparation of fees] Precautions when preparing supplementary materials for the purchase of medical equipment manufacturing equipment |
| According to Article 41, Subsection 3 or Article 42, Subsection 2 of the Act, it is necessary to provide corresponding fees. | [Fee details] Compliance basic requirements standard declaration matching fees Compatible basic requirements standard matching fees Certification basic requirements standard match qualification fees Article 42, Subsection 2 of the Comparative Examination Law [Notice of preparation of fees] Precautions when preparing supplementary materials for the purchase of medical equipment manufacturing equipment |
QMS compatibility training report request document
| Compatibility test report book | [Book registration ceremony] Designated (advanced) controlled medical equipment, etc. Compatibility test report registration form No. 67(1) Foreign Manufactured Designated (Advanced) Controlled Medical Instruments, etc. Compatibility Tuning Certification Book No. 67(2) |
| Attachment | [Fee details] ① Seal of the application for the purpose of manufacturing the requested product, approval of the application, or partial approval of the change. ②ISO13485:2003 certification book etc., self-subject test application application test compliance test within XNUMX years of Nikki, other test provider's current situation report book, standard MOU etc. other partner country certification book Some news reports, foreign exchange machines, etc. Please confirm the suitability of the document. ③ Outline of the experimental production process ④ Outline of the operational activities during the implementation of each design, check the quality management of each design, systematic and interactive resources. ⑤Other necessary expenses specified by the provider. [Notification of preparation] 关于QMS调查查查窶冱(药食监ま发1024No.10) 关于标蠇证和QMS 合性调查文请处法（药食监ま发1119No. 7 /药食机揑1119No. 3） 关于current QMS compatibility test report for multi-product group separate selection (educational program 1121 No. 21) Questions and Answers (Q&A) for medical equipment manufacturing management, quality management, and external testing (editing page 1121, No. 25). |
Frequently asked questions
Instruments for daily health management such as thermometers, blood counts, etc.
Under the current circumstances, the medical equipment that is used in the industry is usually a medical equipment that measures body temperature, blood pressure, etc. In this regard, we will make a small measurement of the amount of equipment that is already in demand, the implementation of medical equipment and equipment, and the method of calculating the amount of demand at the same time.
Thoughts on the song for home use
Home massage belongs to II category of medical equipment. Recently, the size of the massage for home use has changed, the size of the massage has changed, the size has changed, and the time has changed.
Thoughts on opening the keyboard are useful medical instruments that can be used to relieve shoulder pain, promote blood circulation, etc.
The use of magnets for treating affected areas includes existing household permanent magnet magnetic treatment devices with certain options. The demand for medical equipment is now available.
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 application has high level of industry, ability is perfect, and administrative staff is small.
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.
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