This article deals with the Guidelines for Evaluating Requests for an Expert on Papers Demonstrating the Performance and Safety of Medical Devices by Thailand medical device registration. As mentioned in the Ministerial Regulation on Permits, it is appropriate to develop a list of medical devices that must be presented in all topics. To assess the product’s effectiveness and safety, comprehensive lists or notices must be provided to outside experts, such as –
- Medical devices are new technologies, such as innovative products and AI.
- Medical devices can be used by patients at home, such as lasers and LEDs.
- Medical devices evaluated for efficacy and safety, such as hyaluronic acid-free products, silk products, and PRPs.
- Products with a history of severe adverse events or flaws can cause severe environmental damage.
- Medical equipment with specific Ministry of Public Health notifications
A permit request and notice of such a comprehensive list are not required for medical devices, which must submit documentation for all topics as outlined in the Ministerial Regulations. In one of the following situations, the effectiveness and safety of the product do not need to be evaluated by an outside expert by Thailand medical device registration.
- An internal reviewer must assess a device’s performance and safety, and if any issues arise, they may contact an outside expert.
- Government agencies and hospitals have historically been the recipients of medical devices sales, and at least three public universities have been operating for three years.
- A drug that has previously been registered as a medicinal product.
- A specifications declaration must contain the same formulation, ingredients, indications, packaging, manufacturing process, and location as a previously registered license or specifications declaration.
- Requesting authorization for medical devices by referencing original documents and sending paperwork for approved medical devices. No new uses or indications differ from previous ones, but the previous one is acceptable. The same name, formulation, ingredient, indication, primary packaging, manufacturing process, production location, and other details must be the same as those on a previously registered license or specifications declaration receipt. However, the domestic producer or importer’s name has changed, or the producer or reporter’s personality has changed as well.
- It is a medical device that the organization’s Medical Device Control Division has approved or permitted to be registered.
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Source: Medical Device Control Division
