Combination Products, Combination Medical Devices, Kit Products, Kit Components, Assortment Products

“This content is intended for a Japanese audience. Please refer to the original Japanese text for accuracy. Foreign companies doing business in Japan will need support from Japanese-speaking staff due to local language requirements and business practices.”

There are complicated terms/product classifications used by the regulatory authority in Japan. 
I selected confusing terms/product classifications here. 
Regulatory path would be different depending on the classification. 
When you feel your product falls into one of these, please look into applicable regulations. 

1. Combination Products

• Original Definition"A combination product is a single product composed of two or more different types of pharmaceuticals, medical devices, or regenerative medicine products (hereinafter referred to as 'constituent parts')."
  (Source: MHLW, "Partial Amendment to the Handling of Marketing Approval Applications for Combination Products," https://www.mhlw.go.jp/web/t_doc?dataId=00tc2324&dataType=1&pageNo=1)
• Plain Language Explanation
  This refers to a product that is treated as a single new product by combining products from different regulatory categories (e.g., a drug and a medical device). The key feature is that the overall regulatory classification is determined by the product's most important function (its Primary Mode of Action, or PMOA).

2. Combination Medical Devices

• Original Definition"Refers to a medical device that is packaged, etc., by a marketing authorization holder as a single medical device for the purpose of being used as an integrated unit by combining multiple medical devices."
  (Source: MHLW, Notification No. 0331002, March 31, 2009, "Handling of Marketing Approval Applications, Marketing Certification Applications, and Marketing Notifications for Combination Medical Devices," https://www.pmda.go.jp/files/000158673.pdf)
• Plain Language Explanation
  This is a product where all constituent parts are "medical devices" and there is a "clinical necessity" for using them together as a set. This notification defined that such products are not mere assortments but are intentionally packaged as a single product by the marketing authorization holder.

3. Kit Products (Pharmaceuticals)

• Original Definition"'Kit Product' refers to a pharmaceutical product that combines a formulation containing an active ingredient (hereinafter 'primary agent') with a solution, suspension, or another formulation containing other active ingredients (hereinafter 'accompanying agent') for the purpose of dissolution, suspension, or mixing at the time of use, in accordance with its dosage and administration."
  (Source: MHLW, Notification No. 0213005, February 13, 2004, "Handling of Kit Products," https://www.pmda.go.jp/files/000155938.pdf)
• Plain Language Explanation
  This refers to multiple pharmaceutical products that need to be mixed immediately before use and are packaged as a single product. It mainly applies to injectable drugs, and the primary agent and accompanying agent are considered "one pharmaceutical product."

4. In-Vitro Diagnostics (IVDs) and Kit Components

• Original Definition"In this Act, 'in-vitro diagnostic pharmaceutical' means a pharmaceutical intended exclusively for use in the diagnosis of diseases, which is not for direct use on the human or animal body."
  (Source: PMD Act, Article 2, Paragraph 14)
• Plain Language Explanation
  Pharmaceuticals used for diagnosing diseases outside the body, using samples like blood or urine, are also supplied as "kits." The individual parts that make up this kit (reagents, swabs, control solutions, etc.) are referred to as "Kit Components" and are subject to the marketing approval review.

5. Combination Pharmaceuticals, Quasi-drugs, and Medical Devices (Assortment Products)

• Summary of Handling"For products that are merely an assortment of already approved pharmaceuticals, quasi-drugs, or medical devices, a new manufacturing approval is not required, as long as conditions are met such that there is no misunderstanding of the usage/dosage, and the quality of each component is not affected."
  (Source: MHW, Notification No. 633, June 30, 1971, "Handling of Combination Pharmaceuticals, Quasi-drugs, and Medical Devices," https://www.mhlw.go.jp/web/t_doc?dataId=00ta1239&dataType=1&pageNo=1)
• Plain Language Explanation
  This is the regulation for "assortment products," where already-approved products are placed in a single box for convenience of sale. Since the products themselves are not modified, no new approval is required. This forms the basis for the current understanding of "mere assortment products."
  
  @K.Kamitani