Wearable Medical Devices – FDA Regulation & Global Compliance Guide
Elexes often provides start-to-finish regulatory and quality services to clients, particularly those working with innovative technologies like Wearable Medical Devices. One such example is a start-up that was developing a novel wearable device to monitor vital signs. The company needed regulatory approval in Australia, the US, Canada, and Europe, requiring a tailored approach that addressed the unique challenges of wearable technology in different markets.
With our project management skills and thorough knowledge of regulations, we broke down the entire project into several major milestones.
Elexes has supported wearable medical‑device manufacturers through FDA, CE, TGA and Health Canada market. If you’re a med‑tech start‑up or QA/RA lead developing a wearable medical device, here’s how to align your design, classification, and regulatory strategy across multiple jurisdictions.
Key Considerations for Market Entry
For bringing any product to a country’s market, there are FOUR important things to always keep in mind:
1) Meeting applicable wearable medical device regulatory requirements of that country.
2) Having a robust quality system with all associated documents in place.
3) Executing the right testing to support the product’s safety and efficacy.
4) Obtaining regulatory approval of the country.
Tailored Strategies for Global Compliance
Based on a thorough analysis and prior experience with wearables, we defined all requirements for each of the countries at the beginning of the project. This gave our client clarity as to what it will take to bring their device to the respective markets. Once market-specific requirements were defined, Elexes defined action items to fulfill each and every requirement and supported the clients in executing the action items. Some of the action items were – procuring RoHS certifications from component suppliers to fulfill the RoHS requirement, getting FCC certification to fulfill the Bluetooth safety requirement, obtaining IEC 62133 compliance for battery safety, ensuring bio-compatibility for all patient contacting materials, and electrical safety for all electrical components.
Parallelly, Elexes experts created quality systems documents, including design control like the system requirements specifications, design input, design output, and traceability matrix. Testing required to launch the product in Australian, Canadian, European and US markets were defined and presented to the client with rationale. After Elexes and the client were on the same page in terms of testing, Elexes leveraged its relationships with test labs to execute testing. We ensured that the testing was done in accordance to applicable regulations and standards like the IEC 60601, ISO 10993, and ISO 11607.
Aiming for quick deliverance, the sections of the submissions that were independent of test results, like the cover letter, device description, and manufacturing flow chart were prepared early on. After the test results were acquired,Elexes prepared all test dependent sections of submissions within 2 weeks and sent over the submissions to the Australian TGA, Health Canada, US FDA and European Notified Body for review.
Elexes then, corresponded with regulatory bodies and ensured successful clearance of the product for the client.
Need Help With Wearable Device Regulations
FAQs
What qualifies as a wearable medical device under regulatory definitions?
A wearable medical device is a body-worn product intended for diagnosis, monitoring, treatment, or prevention of disease and is regulated based on its intended medical use.
What are the key regulatory pathways for wearable devices in the US, EU, Australia, and Canada?
Wearable devices follow FDA 510(k), De Novo, or PMA routes in the US; CE marking under EU MDR; TGA inclusion in the ARTG in Australia; and Health Canada licensing according to device classification.
How does classification differ for wearables vs traditional medical equipment?
Classification for wearables emphasizes intended use, software functionality, and risk associated with continuous patient contact rather than factors like device size or location of use.
What design controls, software standards, and clinical evidence are needed for wearable medical devices?
Manufacturers must comply with design controls, software lifecycle standards (e.g., IEC 62304), usability engineering, cybersecurity requirements, and provide clinical evidence proportionate to the device’s risk.
What are common compliance pitfalls for wearable device manufacturers and how to avoid them?
Common compliance issues include misclassification, inadequate software validation, weak clinical evidence, and unclear labeling. These can be avoided through early regulatory planning and thorough gap assessments.
