Legal overview of medical equipment, etc.
Updated: July 2024, 3
In order to ensure the safety and speedy delivery of medical equipment, etc., the purpose of legal modification of medical equipment, etc., to ensure the safe and speedy delivery of medical equipment, etc., to provide additional documentation, and to strengthen the provision of medical equipment, etc. fan book Extensive safety measures are taken to ensure the construction and construction of medical equipment and external inspection equipment.
Major repairs to medical equipment
Medical equipment manufacturing industry change
(1) Manufacturer's permission system or approval system can be changed or changed.
In the past, there was a system in which domestic manufacturing was permitted, and a system in which foreign manufacturing and commerce was approved. The existence of past manufacturing divisions has changed, and the manufacturing industry has changed.
| before fixing | After modification | |
| Permissible/Note etc. | Within Japan: Approved, Overseas: Approved | Domestic/Foreign Japan: Notes |
| Validity period | 5 years | 5 years |
| Permissible / Attention, etc. is the main force | Japan: Prefecture, Foreign country: Country | Japan: Prefecture, Foreign country: Country |
| manufacturing division | General, Bacteria, Biology, Packaging, etc. | 无 |
| Permissible/admissible requirements | Failure condition | Failure condition |
| Construction request (Requirements for general/bacteria/biological/packaging categories) | No (necessary matters specified by the new QMS ministerial ordinance) | |
| responsible engineer | 必要 | 必要 |
Due to the nature of the manufacturing process, the classification of general Japanese packaging, etc., and the provisions for the requirements for the production of the educational law, etc. may not be re-applied.
(2) Process changes to meet demand
Previously, it was not possible to create an image of a medical device that required attention to the development of the design.
| Manufacturing process | ①Medical equipment (Other than ②③④) | ② General medical equipment | ③South German case | ④ Mediation of German records |
| design | ○ | × | ○ | ○ |
| Main equipment | ○ | ○ | × | × |
| Sterilization | ○ | ○ | × | × |
| Final product storage in Japan | ○ | ○ | × | ○ |
Changes in medical equipment and equipment
The actual "exchange" itself is defined by the local law, and the new legal regulations regarding the introduction of the new law, "exchange" and "intermediary of the record" are additionally determined as medical equipment.
Please follow the instructions for the medical equipment.
software
1. Used disease diagnosis incident
2. Use of disease treatment cases
3. Cases related to use of disease prevention
recordable media
1. Media for recording and diagnosing diseases
2. Media for record-keeping and disease treatment
3. Media for recording and preventing diseases
Medical equipment manufacturing business approval requirements, compliance requirements, etc. (QMS management, etc.).
QMS institutional structure
(1) QMS ministerial regulations, modification, and related manufacturing costs.
In the past, as a medical equipment manufacturer in China, the requirements were based on the GQP and GVP quality management procedures, but currently the GQP was covered by QMS, and the demand was established as a comprehensive quality management system standard for individual management equipment manufacturers. (Quality management manual).
(2) Compatible with the GQP ministerial QMS system and the requirements for approval of the manufacturing of medical equipment, etc. according to the ministerial ordinance.
《Ministerial Ordinance Compatible with Systematic Standards for Manufacturing Management or Quality Management for Medical Equipment for In-Body Diagnosis》 (Ministry of Health and Welfare Ordinance No. 26 of August 8, 8) Also applicable for general medical equipment Manufacturer: Japanese manufacturer.
(3) Rationalization of product group management
Ministerial Ordinance on Goods Groups (Ministerial Ordinance) ``Enacted by the same group of products or manufactured by the same manufacturing facility, non-renewable demand shall be followed.
Medical equipment certification system change
(1) Note that the third party's approval of the machine's progress is large.
However, it is not a controlled medical equipment, nor a highly controlled medical equipment specified by the Minister of Health and Welfare.
(2) Under the Act on Current Affairs, it is possible to acquire approved goods, to obtain approval for the status of a person, and to obtain approval for goods under the Act on Medical Equipment, etc.
Medical equipment sales regulations
If you do not have the right to purchase, you may not be able to purchase the product without having to pay for it.
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.
