When Do Orthopedic Supports Require ISO 13485?


In the orthopedic support and brace industry—such as joint supports, rehabilitation braces, silicone or gel supports—ISO 13485 is frequently mentioned by brands, importers, and distributors.
However, not all orthopedic supports are required to be manufactured under ISO 13485.

So, when exactly is ISO 13485 required for orthopedic supports?
This article explains the answer clearly from both a regulatory and practical perspective.

1. What Is ISO 13485?

ISO 13485 is an international quality management system (QMS) standard specifically designed for medical devices. It focuses on:

  • Medical device design and development
  • Material and process traceability
  • Risk management
  • Production, inspection, packaging, and shipment control
  • Complaint handling and post-market surveillance

Simply put, if a product is classified as a medical device, ISO 13485 is often a fundamental requirement for global markets.

2. Not All Orthopedic Supports Are Medical Devices

A common misconception is:

“Orthopedic support = medical device = ISO 13485 is mandatory.”

In reality, this is not always true.
Whether ISO 13485 is required depends primarily on the product’s intended use and marketing claims.

3. Situations Where Orthopedic Supports Usually Require ISO 13485

(1.) When the Product Is Classified as a Medical Device

Orthopedic supports are generally considered medical devices if they:

  • Are used to treat, prevent, or alleviate disease or injury
  • Are intended for medical rehabilitation or post-operative support
  • Claim to correct, immobilize, or restrict joint movement
  • Are recommended for use by physicians or physical therapists

※Examples include:

  • Post-operative knee braces
  • Wrist supports for fracture rehabilitation
  • Medical-grade orthopedic insoles
  • Corrective supports for plantar fasciitis or hallux valgus

➡️ These types of products usually require ISO 13485 to be legally marketed in many countries.

(2.) When Exporting to the EU, UK, US, and Other Regulated Markets

If orthopedic supports are sold as medical devices in markets such as:

  • EU European Union (CE / MDR)
  • GB United Kingdom (UKCA)
  • US United States (FDA)
  • JP Japan
  • CA Canada

➡️ ISO 13485 is either a mandatory requirement or a highly expected standard during regulatory review, audits, and distributor evaluations.

(3.) When Working with Medical Brands, Hospitals, or Major Distributors

The following customers typically require ISO 13485 certification:

  • Medical device brands (OEM / ODM projects)
  • Hospitals and healthcare systems
  • Medical supply distributors and pharmacy chains
  • International medical brands, especially in Europe and North America

※For these customers, ISO 13485 represents:

  • Stable and consistent quality
  • Reduced regulatory risk
  • Long-term partnership potential

4. About DIN SIN MEDICAL CORPORATION

DIN SIN MEDICAL CORPORATION is a professional manufacturer specializing in orthopedic supports as well as medical-grade silicone and gel products. We are certified under ISO 13485, the international quality management system standard for medical devices.

In accordance with global medical device requirements, we have established comprehensive quality control and production processes to ensure process stability, material safety, and full traceability, meeting the stringent demands of medical markets.

We provide OEM and ODM manufacturing services, supporting product development, structural design, and mass production planning based on customer requirements. Our team works closely with brand partners to align products with regulatory and market needs across different regions, delivering stable and flexible manufacturing solutions.

Back