FDA Shortened Duration on Permission Request, Depending on Medical Device Risk-Based Classification
20 April 2024

FDA has enhanced convenience for the medical device entrepreneurs by shortening the procedures of granted permission to 15 working days through E-submission for the request of minor change of the medical devices. At the same time, FDA continue regulate the medical devices and protect the consumers efficiently.

Mr. Lertchai Lertvut, the Deputy Secretary-General of the Food and Drug Administration (FDA) revealed that an E-submission was open to facilitate the entrepreneurs who required the minor change such as the changes on medical device manufacturer, name of the product owner, name of the overseas manufacturer with the same establishment’s address. The duration of permission request was cut to 15 working days by streamlining  the evaluation process and time .This facilitates the entrepreneurs with fast service, concise process thus enabling people to access qualified and standardized medical devices that were acceptable internationally. The improvement as previously mentioned, would ensure the use of registered medical devices and raise efficiency in consumer protection. Consequently, the Thai people would be safe from the use of medical devices.

As aforementioned, the shortened duration of permission request is eligible for the case of minor change and such request has to be performed through the E-submission (Skynet). However, the Skynet system is now under improvement.

The Deputy Secretary-General of FDA stated more that FDA prioritize mobilizing Health Economy Policy, hence, FDA has shortened the procedures of granted permission to be convenient, fast service, and reinforce the measures of consumer protection on manufacturing control, the importation, and the sales of medical devices to ensure their quality, efficiency and safety, which would foster the medical device industry expansively and sustainably.


News Publication Date: 20 April 2024