Thailand: Cancellation of Listing Approval Certificate due to Incorrect Risk Classification Category

The Thai Food and Drug Administration issued an infographic regarding an occurrence that may result in the cancellation of the listing approval certificate. 

According to the Ministry of Public Health Notification, manufacturers and importers must submit a listing application for a device, an apparatus, a machine, an object inserted into the body, a solution used for performing a test inside a laboratory, a product, software or any other object intended explicitly by its manufacturer or owner to be used for specific purposes (intended use and Indication). This regulation is as stated in B.E. 2563 (2020), dated 29 December B.E.2563 (2020). Examples of the said group of medical devices are as follows:

1. Medical personal protective equipment (Coverall PPE)
2. Surgical gown or Isolation gown
3. Examination gloves
4. Disposable surgical mask N95 or above
5. Sterile single-use insulin syringe without needle

Any registration that does not correspond to the medical device risk classification category is deemed affected to the consumers’ health and safety. The Thai Food and Drug Administration has the authority to cancel the listing certificate under Section 70/1(1) of the Medical Device Act, B.E.2551 (2008) and its amendments (2^nd Edition, 2019). Suppose it is found that the product submitted for the listing application is not classified as a medical device or is considered a medical device class 2 (two) to 4 (four) but is registered as class 1 (one) with the wrong risk classification category, then the listing approval certificate will be cancelled.

With regard to the above-mentioned information, it was suggested to conduct the following actions prior to submitting an application:

1. To have in-depth knowledge by studying the manual for determining the risk classification of medical devices.
2. To research how to submit risk classification and grouping confirmation before performing an E-submission.
3. To research how to submit a diagnosis letter to consider whether the product is classified as a medical device or not.

The infographic can be accessed here (in Thai). This infographic was posted on the Thai FDA Facebook Page on 05 September 2024 and is already effective.

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