Drugdu.com expert's response:

During the medical device registration or filing process, if the proposed referenced data for the same kind of medical device (including technical documents, clinical trial data, market usage information, etc.) are non-public, meaning these data have not been released through public channels and are protected by intellectual property rights (such as patents, trade secrets, etc.), authorization or permission from the original data holder is typically required to ensure the legitimacy and compliance of the data.

This is because unauthorized use of non-public data may infringe upon the intellectual property rights of the original data holder, leading to legal disputes and regulatory risks. Therefore, when submitting a medical device registration or filing application, corresponding authorization documents or certificates should be attached to prove that the data used were legally obtained.

However, if the data for the same kind of medical device are publicly published data, such as those released through academic journals, professional conferences, government announcements, and other channels, authorization from the original data holder is usually not required. This is because publicly published data have been legally disclosed to the public and are no longer subject to intellectual property protection restrictions.

It should be noted that even when using publicly published data, the accuracy and reliability of the data should be ensured, and relevant laws, regulations, and regulatory requirements should be followed. For example, when citing clinical trial data, the completeness, authenticity, and traceability of the data should be ensured, and they should comply with relevant standards and norms for clinical trial data.

In summary, whether authorization is required for the data of the same kind of medical device depends on the nature and source of the data. Authorization should be obtained legally when using non-public data; when using publicly published data, authorization is usually not required, but compliance with relevant laws, regulations, and regulatory requirements is still necessary. During the medical device registration or filing process, it is important to ensure that the data used are legal, compliant, accurate, and reliable.