Therapeutic Orthoses and Assistive Devices

While both therapeutic orthoses and assistive devices serve to supplement and support bodily functions, they differ significantly in their objectives, the laws that regulate them, their methods of use, and the procedures for manufacturers to have their products covered by public systems. Furthermore, these are separate systems from the insurance reimbursement listing for medical devices under the medical service fee system, so it is necessary to consider which system to target for product commercialization from the business planning stage.


🗂️ 1. Differences in Definitions, Legal Regulations, and Target Users

Therapeutic Orthosis
  • Definition/Objective: An orthosis used temporarily during the treatment process of an illness or injury to immobilize the affected area or substitute its function. Plaster casts and corsets are typical examples.
  • Governing Law: Based on the Health Insurance Act.
  • Target Users: Individuals undergoing treatment for an illness or injury for whom a physician deems the orthosis medically necessary. In principle, individuals are no longer eligible once their symptoms have stabilized (a state where no further improvement can be expected from treatment).

Assistive Device (Hosōgu)
  • Definition/Objective: An item used for an extended period after a disability has stabilized to compensate for lost physical functions and facilitate daily and social life. This includes prosthetic arms/legs, wheelchairs, hearing aids, and walkers.
  • Governing Law: Based on the Act on Comprehensive Support for Persons with Disabilities.
  • Target Users: Individuals, such as holders of a Physical Disability Certificate, who have a permanent physical disability that impedes their daily life.


📜 2. User Procedures and Cost Burden
The procedures for users to obtain these devices and the mechanisms for cost-sharing are entirely different.
In the Case of Therapeutic Orthoses (Reimbursement Payment for Medical Expenses)
The principle is a "reimbursement payment" system, where the user temporarily pays the full amount upfront and is later reimbursed.
  • Physician's Diagnosis/Prescription: A physician determines the orthosis is necessary for treatment and creates a "Fabrication Instruction Form (Medical Opinion)".
  • Fabrication/Purchase: The user has the orthosis fabricated at a prosthetics and orthotics company and pays the full cost out-of-pocket.
  • Application for Benefits: The user applies by submitting the following documents to their health insurance provider (e.g., Japan Health Insurance Association "Kyokai Kenpo," Health Insurance Societies, or municipal National Health Insurance):
    • Application for Medical Expense Benefits
    • Physician's Medical Opinion and Certificate of Fitting
    • Receipt
  • Reimbursement: After a review, the amount minus the co-payment portion (in principle, 10-30%) is transferred to the designated bank account (meaning 70-90% is reimbursed).
  • Reference URLs:

In the Case of Assistive Devices (Assistive Device Expense Benefit System)
Generally, a system where the user pays 10% of the cost as a co-payment (proxy receipt system) is common.
  • Consultation/Application: The user consults with and submits an application, a physician's medical opinion, and other documents to the disability welfare section of their local municipal office.
  • Evaluation: An evaluation is conducted at a Rehabilitation Center for Persons with Disabilities or a similar institution to determine if the assistive device is truly necessary.
  • Decision/Issuance of Ticket: If approved, the municipality issues an "Assistive Device Expense Benefit Decision Notice" and an "Assistive Device Expense Ticket".
  • Fabrication/Receipt: The user gives the ticket to the provider, pays, in principle, 10% of the cost, and receives the assistive device. (The remaining 90% is paid directly from the municipality to the provider.)
  • Reference URL:


⚙️ 3. Manufacturer's Perspective: The Path to Product Adoption

For Ready-Made Therapeutic Orthoses: Aim for "Inclusion in the List"
In addition to custom-made items, ready-made products that meet certain requirements are also eligible for coverage. Manufacturers aim to have their products included in the list specified by the Ministry of Health, Labour and Welfare (MHLW).
  • Application: A manufacturer submits materials (survey forms and proposals) demonstrating the product's effectiveness, safety, and price validity to the Japan Orthotics & Prosthetics Association, which serves as the application window. The association organizes and reviews the content before submitting a formal proposal to the MHLW (Health Insurance Bureau, Medical Economics Division).
  • Review: Upon receiving the proposal, the MHLW requests a review by the "Working Group for Reviewing the Listing of Ready-Made Orthoses," which is composed of experts. This group assesses whether the product has functions and effects equivalent to custom-made items.
  • Listing: If approved by the working group and after final deliberation by an expert committee, the product is included in the list via a notice from the MHLW and becomes eligible for medical expense reimbursement.
  • Reference URLs:

For Assistive Devices: Aim for Designation as "Finished Components"
The price of an assistive device is calculated based on standard amounts set by the government. This standard is composed of the cumulative prices of various "components," and manufacturers must have their products designated as "Finished Components" on this official price list.
  • Application Window: The National Rehabilitation Center for Persons with Disabilities serves as the application window.
  • Application: Within a specified period each year (typically July-September), manufacturers submit application forms, product samples, and clinical evaluation data.
  • Evaluation/Review: The National Rehabilitation Center for Persons with Disabilities evaluates and reviews the product's functionality, durability, and price validity.
  • Designation/Notice: Once approved, the product is designated as a "Finished Component" by a public notice from the MHLW and becomes eligible for the Assistive Device Expense Benefit System. This allows prosthetics and orthotics companies nationwide to use the component to fabricate assistive devices.
  • Reference URL:


🔬 4. Difference from Medical Device Insurance Listing

The systems for therapeutic orthoses and assistive devices are fundamentally different from the general insurance reimbursement listing for medical devices.

Thus, while therapeutic orthoses and assistive devices are operated within the frameworks of "welfare" and "recuperation," medical devices undergo a strict approval and price determination process within the framework of "medical care," which is a major difference.


Other Reference URLs:
＠K.Kamitani
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