CMDE Releases Key Guidelines for Clinical Evaluation of Medical Devices

On March 18, 2024, the Center for Medical Device Evaluation (CMDE) released an important Notice that highlights the recommended approach for the clinical evaluation of products in alignment with the Medical Device Classification Catalog (2024 Supplement) (No. 11, 2024). This announcement marks a significant milestone in ensuring the safety and efficacy of medical devices in the market.

The Notice comprises two essential document attachments:

  1. The first attachment provides detailed instructions for leveraging the recommended pathway for clinical evaluation of related products within the "Classification Catalogue of Medical Devices" (2024 Supplement). This comprehensive guide offers insights into the regulatory framework and procedural steps necessary for conducting thorough clinical assessments.
  2. The second document attachment focuses exclusively on the recommended path for clinical evaluation of related products within the same catalog. This targeted resource delves deeper into specific criteria and considerations pertinent to the evaluation process, facilitating a more nuanced understanding for stakeholders involved in the medical device industry.

For those seeking further information, the complete Notice and document attachments can be accessed via the CMDE website here. (Available in English)

CMDE's proactive efforts in providing clear guidelines for clinical evaluation show their commitment to upholding rigorous standards in the medical device sector. By equipping stakeholders with valuable resources and insights, CMDE plays a pivotal role in fostering innovation while safeguarding patient health and well-being.