Medical device development support

Updated: July 2024, 9

New medical devices are being created every day as technology advances and social demands change.

　

However, in the case of a medical device planned by a company that has not previously handled medical devices, or when trying to import and sell a medical device from overseas that does not have a similar product in Japan, it is necessary to comply with the standards of the Pharmaceutical Affairs Law. We often see cases where development is proceeding without being aware of this.

When trying to obtain approval/certification for a medical device, the steps differ greatly depending on whether it is a generic product (equivalent to the preceding medical device or a minor change).

In fact, the more groundbreaking the product is, the more difficult it may be to obtain medical device approval and certification.

At our company, we also provide consulting services to people who are trying to supply new medical devices to the market.For medical devices that are about to be commercialized, we handle everything from the planning stage to prototyping, obtaining approval and certification, and mass production. If the product has already been used as a medical device overseas, we will conduct an investigation to ensure that it complies with Japanese standards.

Common cases

A case where a doctor plans and develops a new medical device from the treatment field

There are medical devices that are born from treatment based on the professor's unique theories. Additionally, there are medical devices that are created by making improvements to already common medical devices.

　

In many cases, doctors do not need to register the device as a medical device as long as they use it only for their own treatment, but if they want to sell it to other doctors or have it used by more patients. If so, you will need to register the medical device.

Cases in which medical devices are planned and developed by a manufacturer that is not a medical device manufacturer

This is a case where a company that has previously developed and manufactured industrial products and systems can move forward with the development of medical devices.

　

There are many cases where new medical devices are devised that have never existed before, but in the case of medical devices, it is necessary to develop them with final approval and certification in mind.

We also support QMS compliance for factories that are already operating ISO9001.

A case where a company that has not previously handled medical devices imports and sells overseas medical devices.

We often receive inquiries about selling medical devices handled by overseas business partners in Japan.

　

In the case of medical devices, unlike other miscellaneous goods or industrial products, even if the product is expected to be effective, it is necessary to consider whether it can obtain medical device approval.

　

We provide support from the initial research phase before specific product implementation.

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.