Manufacture and sell medical devices
Updated: July 2026, 2
To manufacture and sell medical devices domestically
To manufacture medical devices domestically and ship them to the market,Manufacturing and sales licensewithManufacturing industry registrationBoth are required.
Flowchart ① Procedures for Manufacturing Permits and Registration below describes which licenses and registrations are required depending on the business to be performed, and Flowchart ② describes the procedures for each item according to the classification of medical devices. is.
Junya Yamada
What is medical device manufacturing and sales industry?
After manufacturing medical devices (including cases where manufacturing is outsourced to others) or importing medical devices manufactured overseas, selling, lending, or giving medical devices to distributors, etc. , is responsible for distributing medical devices to the market. This also applies to the provision of programmed medical devices via telecommunications lines.
Manufactured or imported medical devices can only be sold, loaned, or given to distributors or lenders, and cannot be sold to clinics or general consumers with this license.
Types of manufacturing and sales licenses
| Classes | Category | Type of permission | Applicant |
| Ⅳ | Highly managed medical equipment | First-class medical device manufacturing and sales license | Prefectures |
| Ⅲ | |||
| Ⅱ | managed medical equipment | Type 2 medical device manufacturing and sales business license | |
| I | General medical equipment | Type 3 medical device manufacturing and sales business license |
Manufacturing and sales license requirements
Regarding the license requirements for manufacturing and sales business, please refer to “Manufacturing and sales license requirementsPlease check the page.
What is medical device manufacturing industry?
A manufacturing facility that manufactures medical devices as a business under contract from a medical device manufacturer must be registered as a medical device manufacturer.
Registration for medical device manufacturing must be done for each manufacturing facility, not for each company.
The manufacturing processes covered are the design, main assembly, sterilization, and final product storage processes, and any manufacturing facility that performs this process must be registered as a medical device manufacturer.
Before the revision in 2014, the design process was not included, but after the revision, it was newly added. Additionally, after the revision, packaging and display processes such as labeling are no longer covered.
This manufacturing industry registration is not required for manufacturing facilities that manufacture assembly processes or parts that are not the main assembly.
Scope of manufacturing facilities subject to registration
Processes that require manufacturing include design, main assembly, sterilization, and storage of finished products, and are defined as follows.
| Process | Message |
| Design | A facility where there is a person responsible for the design and development of medical devices that require approval or certification, and where records related to the design and development are managed. |
| Main assembly | Facilities that have actual manufacturing operations and are substantially responsible for the quality control supervision system or product realization related to the item. |
| sterile | Facilities that sterilize sterilized medical devices |
| Storage of final products | Among the facilities that store the final product, the facility that stores the product at the time of determining whether to release it to the market |
Whether or not a manufacturing industry is registered is as follows. The process in which manufacturing industry registration is required varies depending on the type of medical device.
| Manufacturing process | Medical equipment (other than right) | Class I medical device | Single program | Single program recording medium |
| Design | 必要 | Must not | 必要 | 必要 |
| Main assembly | 必要 | 必要 | Must not | Must not |
| sterile | 必要 | 必要 | Must not | Must not |
| Storage of final products | 必要 | 必要 | Must not | 必要 |
Medical device manufacturing industry registration requirements
For more information on manufacturing industry registration requirements, seeManufacturing industry registration requirementsPlease check the page.
Medical device item procedures
In order to distribute individual medical devices on the market, it is necessary to obtain the permission and registration mentioned above and then complete the procedures for each medical device. Medical devices are classified into classes, and procedures must be followed accordingly.
| Classes | Application name | Applicant |
| General medical equipment (class I) | Manufacturing and sales notification | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Controlled medical equipment (class II) | Application for manufacturing and sales certification | Third party certification body or Pharmaceuticals and Medical Devices Agency (PMDA) |
| Highly controlled medical devices (class III/IV) | Application for manufacturing and sales approval | Third party certification body or Pharmaceuticals and Medical Devices Agency (PMDA) |
For consultation regarding permits and licenses regarding medical devices, please contact Support Administrative Scrivener Corporation.
At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors.
Applications for medical devices are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.
We provide legal services related to medical devices based on the know-how and track record that we can accumulate because we are administrative scriveners who handle applications and negotiations with administrative agencies on behalf of companies on a daily basis.
Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.
Our dedicated staff handles cases nationwide.
