Self Test at Home Kit in Japan_Fundamental
Seeing a doctor online has become popular in Japan.
It will continue to grow for a while. And next to that growth, I believe there will also be growth in "self test at home kit".
This category, which is also attracting attention as an antigen test kit for Covid-19, will continue to release various products.
I'll try to write a basic overview this time.
Supervision of "Self Test at Home Kit" in Japan
First, Let's classify "Self Test at Home Kit" into two categories, - one that can provide its rapid results at home, and one that provides its result through an inspection agency.
(Note: Neither is allowed to provide a diagnosis because only doctors are allowed to diagnose in Japanese law)
A test kit that provides its rapid results at home
This is a type of product in which the consumer collects a sample at home, etc., and obtains the results on the spot.
This includes urine test strips, pregnancy test kits, and antigen test kits for the new coronavirus.
This type of product is handled differently under the PMD Act. depending on the purpose of use.
Roughly speaking, it goes like this .
- If the product is for medical diagnosing assistance -> It's categorized in In-vitro diagnostics (IVDs)
- Of these, pharmaceuticals for prescription cannot be obtained unless prescribed by a doctor in principle. (Special measures that exist as of July 2022: General consumers can purchase this at pharmacies with pharmacists / General businesses can purchase this from pharmaceutical wholesalers.)
- Of these, four types of over-the-counter medicines as test reagents have been approved. 
- Urine suger, Urine protein and Pregnancy hCG -> schedule II pharmaceuticals ->pharmacists or registered sales clerks are allowed to sell at pharmacies
- Luteinizing hormone（LH）->schedule I pharmaceuticals->pharmacists are allowed to sell at pharmacies
- If the prodct is for other purposes -> unregulated products (include products for laboratory)
If it falls under in-vitro diagnostics, permission and approval procedures based on the PMD Act. are required. Although it takes time and effort, quality is ensured through the approval procedures, and there is also the possibility of Japanese insurance reimbursement.
If the product is categorized as unregulated products, the quality is guaranteed only by the manufacturer.
Due to this quality guarantee, that is, the reliability of the results, the Ministry of Health, Labor and Welfare has enlightened to use "medical use (= in-vitro diagnostic drug)" not "research use (= unregulated products)" for self-checks regarding the new coronavirus.
Some in-vitro diagnostics contain medical devices (lancets, dissectors, cotton swabs, etc.) to collect specimens.
It seems that many of those products are applying for approval as "combination products" that combine pharmaceutical and medical devices.
A test kit that provides its results through an inspection agency
This is a type of product in which the consumer collects a sample at home, etc., and sends the sample to an inspection agency for detection.
This includes Inspection service by mail, PCR test kit.
Medical devices (lancets, dissectors, cotton swabs, etc.) may be used to collect specimens.
Points to keep in mind when doing business with home test kits/services
Regarding home test kits, as mentioned above, the PMD Act is one point, but there is another important point. It is Medical Practitioners' Act.
The Law says "No person except a medical practitioner may engage in medical practice." in article 17.
It is no exaggeration to say that whether or not home test kits/services conflict with this Law is the most important point in doing business.
(Although I could not confirm the description in the clear text, as far as I can see the notifications issued by the Ministry of Health, Labor and Welfare, I believe that "diagnosis and treatment" is currently considered to be a work permitted only to doctors.)
As I mentioned at the beginning, I believe that various test kits/services will appear on the market in the future.
The Japanese government also expects this market to expand in the future, and is trying to create appropriate regulations.
Companies that want to do business in this field need to carefully consider how to develop their products/services within the legal restrictions.
If this point is left vague, the product may not be able to clear customs in the first place.
Oggo.jp supports companies that want to do business in the healthcare field, so if you have any problems, please feel free to contact Oggo.jp.
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