Manufacturing medical equipment
Updated: July 2024, 3
table of contents
Manufacturing medical equipment
Regarding domestically manufactured medical equipment in Japan, at the same time, the demand for manufacturing is also available.
In the flow chart below, ① the actual manufacturing process can be ordered manually, ② the required procedure for each individual medical equipment product category.
Is it a medical equipment manufacturing business?
This means that the medical equipment manufactured by the manufacturer (includes the circumstances of manufacturing by others), the medical equipment manufactured overseas by the manufacturer, and the costs incurred by the purchaser, the tax or the award, etc., the medical equipment manufactured in the market. It also provides comprehensive communication and mutual communication with medical equipment.
Manufacture or development of medical equipment, but not limited to salespersons or taxpayers;
Manufacturer's permissible categories
| 类别 | Category | Type of permission | Application reception department door |
| Ⅳ | Highly managed medical equipment | The first type of medical equipment manufacturing business is permitted. | prefecture |
| Ⅲ | |||
| Ⅱ | management medical equipment | Second type medical equipment manufacturing business allowed | |
| I | General medicine equipment | Licensed to manufacture third-party medical equipment |
Manufacturing permit requirements
Please take a look at the detailed content of the current manufacturing industry's permission requirements.
Is it a medical equipment manufacturing industry?
Medical equipment manufacturing manufacturers must be ordered by medical equipment manufacturers.
The focus of this kind of medical equipment manufacturing industry is that each manufacturing facility must proceed individually, but not each individual company.
The manufacturing process includes design, main equipment, sterilizing finished products, etc. The production process requires a manufacturing facility for medical equipment manufacturers.
Before the 2014 reform, the design process was not included, but after the reform, the new design was added. Other than that, after modification, there will be no re-inclusive packaging and labeling instructions.
Non-production major equipment manufacturing plant, non-demand medical equipment manufacturing industry.
Demand-oriented manufacturing facilities
Required step-by-step manufacturing process comprehensive design, main equipment, sterilizer, finished product manufacturer, and the following:
| Process | Message |
| design | Each location for the design and development of medical equipment, management, approval, approval, and approval of each product. |
| Main equipment | During the actual manufacturing process, the product quality management system or production quality management system |
| Sterilization | Bacterial medical equipment, advanced bactericidal equipment |
| Finished product store | In-store product development, in-stock product development prior to product release |
A look at the trends in demand and manufacturing industry. The different types of medical equipment are different, and the demand for each level of manufacturing and manufacturing industry is different.
| Manufacturing process | medical instruments (Inclusive) | ⅠMedical equipment | order of purchase | hard case system |
| design | need | Must not | need | need |
| Main equipment | need | need | Must not | Must not |
| Sterilization | need | need | Must not | Must not |
| Finished product store | need | need | Must not | need |
Medical equipment manufacturing industry requirements
Take a look at the requirements for the current medical equipment manufacturing industry.
Manual of each medical equipment category
If you are in the market for each medical equipment, you can obtain the above information, or after completing the above, the demand for each individual medical equipment will be completed. Medical equipment must be divided into various categories, and the principles are consistent.
| 类别 | Application name | Application reception department door |
| General medicine equipment (I category) | Manufacturing plan | Medical equipment assembly (PMDA) |
| management medical equipment (Class II) | Manufacturer's certification | Third party authentication mechanism or Medical equipment assembly (PMDA) |
| Highly controlled medical equipment (III/IV categories) | Manufacture bill ratification application | Third party authentication mechanism or Medical equipment assembly (PMDA) |
Licenses and medical equipment are available, approved and approved by us.
We welcome new medical equipment businesses and existing manufacturing companies, production companies, Japanese medical equipment businesses, and other companies that offer Japanese medical equipment, etc., and support Japanese legal filings.
The application of medical equipment is highly industrialized, and its capabilities are perfect compared to administrative personnel.
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 team is located in the prefectures owned by Japan. You must receive additional information from our contact system.
