When is a manufacturing and marketing license required to be obtained?

When must a manufacturing and marketing license be obtained?

Under Japanese law, a manufacturing and marketing license is required for a medical device company to market its own branded products.
In the case of medical devices, the type of business license varies depending on the risk of the product to be manufactured and sold.

  • Class I manufacturer and seller General medical device (Class I)
  • Type II manufacturer and seller Controlled medical device (Class II)
  • Class III manufacturer and seller Highly controlled medical devices (Class III, IV)

A business license can be obtained by submitting an application to the Pharmaceutical Affairs Division of the prefectural government office where the head office is located (the building where the general manager is stationed) and passing a conformity survey.

The duties of the manufacturer and distributor are as follows

  • Obtaining marketing authorization/certification or notification of medical devices
  • Implementation of post-marketing safety management
  • Operation of a QMS that manages the entire supply chain of medical devices to be manufactured and sold

It should be noted that a manufacturer and distributor cannot “manufacture” or “sell”
For “manufacturing,” a manufacturing registration is required, and for selling, a permit or notification is required, depending on the class.

The manufacturer and distributor must also have the following five officers who are legally responsible for the following

・Medical Device General Manufacturing and Marketing Manager
・Domestic Quality Business Operations Manager
・Responsible for safety management
Note that there are different requirements for concurrent positions depending on the type of business.

By the way, there is a question that is often asked by start-up companies. When must a manufacturing and marketing license be obtained?
The answer is at the latest until item approval/certification. Note, however, that an item application cannot be submitted unless a business license application has been submitted.
Also, as noted earlier in this newsletter, ISO 13485 certification is not required.

On the other hand, the United States and Europe, for example, do not have a business license system. Therefore, anyone can apply for a medical device if it is under design and development.

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