Do medical devices need annual audits and inspections?

Hello, medical devices do require periodic audits and inspections to ensure their safety and effectiveness. However, the specific annual audit and inspection requirements may vary depending on the country/region's regulations, the type of device, and whether the device is used in a manufacturing, business, or utilization segment.

Generally:

Medical device manufacturing licenses do not require annual review, but need to be replaced with a new license upon expiration.

Medical device business licenses usually don't need annual inspection during the validity period, but companies need to submit self-inspection reports every year and accept on-site inspections by the FDA.

The medical device registration license has a validity period, usually a few years (e.g., 5 years), and the expiration of the registration needs to be renewed.

For some specific regions or international standards, such as the Australian TGA certification and the Eurasian Economic Union (EAEU) registration, medical devices may need to undergo periodic annual reviews (annual audits) to maintain their market compliance.

Therefore, the need for annual review or annual examination, as well as the specific process and requirements, need to be implemented with reference to the local drug regulatory authorities. If there is a detailed need for a specific region or a question for a certain type of medical device, it is recommended to consult directly with the local regulatory agency or professional legal counsel.

If my answer is helpful to you, please give a five-star praise (in the lower left corner of the evaluation Oh), look forward to your favorable comments, and again, I wish you good health, happy mood!