[Column] M&A in the medical device industry
Updated: July 2026, 4
Updated: January 2021
This time,“M&A of medical device manufacturers” from the perspective of licensingI will talk about.
(Please see our specialized page for information on obtaining permission for the medical device manufacturing and sales industry.)
M&A transactions involving licenses and permits are prone to numerous problems.
We have summarized the advantages, disadvantages, and points to note from the perspectives of the "seller side" and the "buyer side."
M&A from the “seller side” perspective
What are the advantages and disadvantages of M&A from the seller's perspective?
●Benefits
If we can maintain our license without going out of business, we can continue to offer our products and ensure the business continues, which will not inconvenience our customers or doctors. This is especially true for products used in hospitals and large medical institutions, as it will ensure a stable supply.
・Selling prices are high because the licenses have high hurdles to obtain.
・Demand is surprisingly high for projects with high hurdles and permits.
●Drawbacks
・Due to a lack of understanding on the part of the buyer regarding permits and licenses, the transfer may be difficult.
・As licenses and licenses are issued to corporations, they cannot be transferred in the case of business transfer. (Transferable if shares are transferred)
● Notes
・If you do not properly check the permits and licenses before buying or selling, you may run into big trouble.
- It is necessary to confirm whether the QMS/GVP system and operation before the transfer was accurate.
- In the case of a business transfer, licenses and permits will not be retained. If the license and permit requirements are also being transferred, it is necessary to inform the buyer that a new certification process will be required.
M&A from the “buyer side” perspective
What are the advantages and disadvantages of M&A from a buyer's perspective?
●Benefits
- Easily enter the medical device industry, which has high barriers to entry.
- Saves time required to obtain permits. (Especially if you can inherit the product, it will save you six months to several years.)
・Since you can start your business right away, it can lead to sales quickly.
● Disadvantages
・In the case of business transfer, licenses and licenses are not available, so it is necessary to obtain them again. (Permission can be obtained if the required person is also transferred)
・Responses must be taken when quality or safety issues arise with products made before transfer.
・If QMS, GVP, etc. are not being operated properly, maintenance will be required.
● Notes
・It is necessary to thoroughly confirm whether the M&A can maintain approval and approval.
・The schedule in case it becomes necessary to re-obtain permits is important.
・If you do not study the knowledge of permits and licenses in advance, it will be difficult to manage the property after the transfer.
・It is important to investigate whether there have been any problems with the product in the past.
It is also important to confirm relationships with medical device manufacturers, wholesalers, and distributors.
What do you think of the above?
We will continue to share various information regarding M&A in the medical device manufacturing and sales industries.
The number of hospitals in Japan is decreasing, and the joint purchasing of medical and treatment equipment is increasing.
If you are actually considering an M&A, you should conduct research in a way that suits your company's circumstances, while referring to case studies and other resources.
