Medical device manufacturing and sales industry, manufacturing industry, manufacturing and sales approval and certification
Notification of general medical devices
Updated: July 2024, 9
General medical devices fall under Class I, and among medical devices, they have the lowest impact on the human body in the event of a malfunction.
Therefore, it is easier to obtain permits and register medical devices than other classes of medical devices, and it can be said that the hurdles for companies entering the medical device industry or starting a new business are low. .
At Support Administrative Scrivener Corporation, we support those who are considering distributing general medical devices that fall under Class I to the market.
Examples of class 1 general medical devices
There are approximately 1200 types of Class I classification. A typical example is as follows.
common name
Name definition
Eyeglass lenses
A glass or plastic device used to correct refractive errors according to a prescription or to protect the eye from radiation or mechanical hazards. For example, protection may be attached to the plane of the glasses.
body motion sensor
A sensor used to detect body movement. Usually used to evaluate sleep disorders (insomnia, snoring, sleep apnea, etc.).
reusable injection needles
A thin, pointed metal tube used to inject or remove liquids by penetrating the skin. This product can be reused after sterilization.
General purpose syringe
An instrument used to inject, inject, or withdraw liquid or gas. Usually made of glass or plastic, it consists of a graduated container and a plunger. A syringe needle is often used to administer drugs or draw blood.
needle holder
A surgical instrument with a handle. The tip of the blade from the distal end to the pivot point has various shapes and is designed to grip the suture needle during suturing.
elastic stockings
Medical elastic stockings (including elastic sleeves for arms) used for the purpose of promoting venous return, such as reducing or preventing stasis of venous blood and lymph fluid in the extremities. It has the function of gradually decreasing pressure from the periphery to the center.
Medical device manufacturing and sales notification for general medical devices (class I)
Manufacturers and distributors can distribute the product domestically by applying for a medical device manufacturing and sales notification to the Pharmaceuticals and Medical Devices Agency (PMDA). This application is called a medical device manufacturing and sales notification.
Because the impact on the human body in the event of a malfunction is low, the government tends to leave it to manufacturers to take responsibility for themselves, and the manufacturing and sales notification of medical devices is literally a notification system.
There will be no review of the content of the application. Basically, it will be possible to start sales and imports at the same time as acceptance.
Items to be included in medical device manufacturing and sales notification
One
Types of manufacturing and sales licenses
Two
Manufacturing and sales license number and date
Three
CAD
Four
Name
Five
Purpose of use or effect
6
Shape, structure and principle
Seven
Place of origin
8
Performance and safety standards
Nine
How To Use
Ten
Storage method and shelf life
Eleven
Manufacturing method
Twelve
Manufacturing site for items manufactured and sold
13
Notes - Manufacturing and sales notification number for the item - If it falls under a specified maintenance management medical device, state that fact - If it is for single use, state that - A photo that allows you to understand the appearance of the item - Definition of a general medical device Materials explaining that this applies to
Pursuant to Article 114-47, Paragraph XNUMX of the Enforcement Regulations, it is also necessary to attach the draft package insert for the product to the manufacturing and sales notification.
Frequently asked questions
I want to sell OEM-manufactured compression socks, compression tights, and compression sleeves as medical devices.
Compression socks, compression tights, and compression sleeves can be sold as medical devices if they fall under the definition of "compression stockings," which is defined as a general medical device.
I want to import reading glasses from overseas and sell them domestically.
These days, reading glasses are sold at 100 yen shops and other places, and although they are not generally recognized as medical devices, they are a medical device that has an excellent effect on correcting vision. Reading glasses are defined as "glasses".
I want to sell test kits that carry out tests in collaboration with medical institutions.
Depending on the subject of the test, they are divided into general medical devices, controlled medical devices, and highly controlled medical devices. Recently, test kits are often seen as general medical devices.
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 every day.
Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.
