Madoka Murakami: Femtech Products and Recent Initiatives from a Medical Device Regulation Perspective

2022/03/16

I first encountered the term "Femtech" in the autumn of 2020, just after being assigned to my current department, a year often referred to as the first year of Femtech in Japan.

Following the activities of the Parliamentary League for the Promotion of Femtech established in October of that year, the "Promotion of Femtech" was explicitly mentioned in the "Basic Policy on Economic and Fiscal Management and Reform 2021" and the "Priority Policy for Women's Empowerment and Gender Equality 2021," both approved by the Cabinet in June 2021. Currently, as part of the activities to promote Femtech, a public-private working group is discussing the regulatory positioning and detailed requirements for various Femtech products.

In Japan, medical devices are regulated by a law known as the PMDA Act*1 to ensure that products with guaranteed quality, efficacy, and safety are distributed. A medical device is defined as an instrument or apparatus intended for use in the "diagnosis, treatment, or prevention of disease" or intended to "affect the structure or functions of the body"*2. In other words, any instrument or apparatus intended for distribution with such purposes is subject to regulation under the PMDA Act. This is no exception for Femtech products.

Among products used for events specific to the female body or related to female genitalia, many are sold as general goods without claiming medical purposes to avoid pharmaceutical regulations, even if they essentially have purposes that fall under the medical device category mentioned above. For such products, especially those inserted into the vagina, there has been a persistent image of being "adult toys," and because their medical purpose cannot be stated publicly, it has been difficult to gain general understanding. During recent discussions on promoting Femtech, it was pointed out that by clarifying the original purpose and delivering it to consumers, Femtech products could spread correctly and truly contribute to women's health. On the other hand, some voices expressed that pharmaceutical regulations pose a significant hurdle for businesses.

Medical devices are organized into categories called "Generic Names," such as "Adhesive Bandages," "Total Hip Prostheses," and "Coronary Stents." Furthermore, each generic name is accompanied by a definition so that it is clear which products fall into that category. As of October 8, 2021, there are a total of 4,406 generic names for medical devices, but new medical devices, including Femtech products, often do not fit into existing generic names.

In such cases, the Ministry of Health, Labour and Welfare responds by changing the definition of an existing generic name or creating a new one. For example, when menstrual cups appeared as products for processing menstrual blood, the ministry responded by adding "cup-shaped packing" to the definition of the generic name "Menstrual Tampon," positioning it as a medical device falling under this category. More recently, as a new category related to Femtech products, the generic name "Cervical Cap" was created for use in preventing the outflow of semen by fitting it over the cervix after sexual intercourse.

However, if a company is unfamiliar with medical device regulations, they may hesitate, thinking that their product might not be recognized as a medical device because there is no existing name, or that it will take an enormous amount of time and money. Similarly, regulatory authorities also struggle with how to define or evaluate medical devices with purposes they have never seen before. To solve this, the shortest path is for both parties to deepen their understanding of regulations and products and to have a common language, which is currently being practiced in the public-private working group I introduced at the beginning.

The word "regulation" may carry an image of a barrier. In the discussions on promoting Femtech, there were many opinions that pharmaceutical regulations would hinder the spread of Femtech products. Certainly, there are difficult aspects, such as complying with various regulatory requirements. On the other hand, regulating means that the government also joins the circle of stakeholders. By the government setting the necessary requirements to ensure quality, efficacy, and safety, and companies distributing products that clear those requirements to gain the trust of users, I believe this will support the healthy spread of Femtech products that have a purpose as a medical device.

I keep in mind that what is required of us as regulatory authorities at this time is the ability to set lean and effective requirements based on an understanding of the products.

I hope that the spread of Femtech will serve as a catalyst for people, regardless of gender, to rediscover the importance of understanding and taking care of their own bodies, and that the world will become more understanding and compassionate toward the physical changes of family members and those around them. To that end, it would be my greatest honor if I could be of even a little help through the tool of medical device regulation.

(Postscript: This article represents personal views and does not represent the organization to which I belong.)