Outline of the case
An American company licensed a program (software) for a medical device to a Japanese company and was asked to investigate whether the license violated the stipulations of Japan’s Pharmaceutical and Medical Devices Law (Law Concerning Assurance of Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices and Other Products). Previously, software alone was not subject to regulation under the Pharmaceutical and Medical Devices Law, but only when it was incorporated into a piece of hardware was it considered a medical device and thus subject to regulation under the Pharmaceutical and Medical Devices Law. However, when the Pharmaceutical and Medical Devices Law was revised to become the Law, medical device programs became subject to the Pharmaceutical and Medical Devices Law on their own. Therefore, the client wanted us to confirm that if a program to be licensed to a Japanese company by the client falls under the category of medical devices, the software license itself falls under the category of “manufacture and sale” and is subject to permission and notification under the Pharmaceutical and Medical Devices Law. The client also asked us to prepare a brief memorandum and report in English on the results of that research.
Services offered by Kuribayashi Sogo Law Office
Kuribayashi Sogo Law Office investigated and confirmed that, due to the enforcement of the Pharmaceutical and Medical Devices Law, the medical program itself is regulated as a medical device under the Pharmaceutical and Medical Devices Law. We also found that if the said program falls under the category of medical devices regulated by the Pharmaceutical and Medical Devices Law, licensing the software to a Japanese company also falls under the category of “manufacture and sale” and requires notification to and permission from the Ministry of Health, Labor and Welfare (MHLW). However, medical devices are classified into general medical devices, controlled medical devices, and highly controlled medical devices, and are internationally classified into Classes I through IV. It was found that general medical devices (those that have little or no effect on the life or health of the patient) are not subject to regulation under the Pharmaceutical and Medical Devices Law. The software that the U.S. company was licensing in this case was also intended to be used for blood analysis and other purposes, but was not considered to have any impact on the patient’s life or limb. Therefore, we submitted a memorandum in English stating that the software in question falls under Class I of the International Classification and is classified as a general medical device in Japan and is not subject to regulation under the Pharmaceutical and Medical Devices Law.
Support for Foreign Companies by Kuribayashi Sogo Law Office
At the request of foreign corporations, Kuribayashi Sogo Law Office conducts research and prepares reports on regulations under Japanese laws and regulations. The report may be in the form of a Legal Opinion or a Memorandum. A legal opinion or memorandum is a typical memorandum of opinion that expresses an opinion as to whether or not the company is validly incorporated and exists, whether or not the representative has the authority to act on behalf of the company, and whether or not the person signing the contract is the representative himself/herself. In some cases, such as a letter of opinion regarding a third-party allotment of new shares, the client is asked to confirm whether or not the document is in compliance with the Companies Act and the Financial Instruments and Exchange Act. Others, when requested by the client, introduce the various laws and regulations and set forth what permits and licenses the company needs to obtain or comply with in order to conduct its business. Laws covered by such memorandam and legal opinions include the Unfair Competition Prevention Law, Premiums and Representation Law, Antimonopoly Law, Subcontract Law, Pharmaceutical Machine Law, Patent Law, Trademark Law, Consumer Contract Law, Worker Dispatching Law, Financial Instruments and Exchange Law, Construction Business Law, Liquor Tax Law, Secondhand Articles Dealer Law, Pawnshop Business Law, Building Lots and Building Transaction Business Law, Entertainment Business Law, and Ryokan Business Law. Thus, for a foreign corporation or a subsidiary of a foreign corporation newly starting business in Japan, obtaining a legal opinion or memorandum from our firm will provide a comprehensive understanding of the laws and regulations governing doing business in Japan. In addition to business law, it is also possible to understand economic laws such as Antitrust Law, Unfair Competition Prevention Law, and Consumer Protection Law. When requested by our foreign corporate clients, we also file various notifications on their behalf, including those for antique dealers, dispatch service providers, and adult entertainment businesses.
Fees (excluding consumption tax)
Kuribayashi Sogo Law Office often accepts cases for a fixed fee for preparing a legal opinion or a memorandum as a result of research on laws and regulations. The amount of the fixed fee depends on the content of the case, but the amount of attorney’s fees for researching Japanese laws and regulations and submitting a memorandum in English is often estimated to be in the range of 400,000 to 600,000 yen. If we are asked to prepare a legal opinion or memorandum in English, we may charge an additional translation fee depending on the content, but in most cases, the translation fee will be included in the above amount. Please inquire for details on a case-by-case basis.