How to register medical apparatus in Thailand?
A distinguishing feature of the registration process in Thailand is classification management. Depending on the purpose of the product and the degree of risk, medical apparatus is divided into different categories, ranging from low-risk to high-risk categories. Different categories correspond to different approval processes and data requirements. Usually, registration of low-risk categories is simpler, while high-risk categories require more clinical trials or verification data.
II. Detailed steps for registration of medical apparatus in Thailand
1. Understanding product classification and regulatory requirements
Before starting registration, first confirm the classification of the product. This step is very critical because different categories of products correspond to different registration procedures. Enterprises should consult relevant Thai regulations to clarify the category, definition and corresponding regulatory documents of the product. Generally speaking, Thai regulations will specify the approval process, required information and approval time for different categories of products.
2. Preparation of registration materials
preparation of materials is the most critical part of the whole registration process. Usually include the following:
- Product technical information: including product specifications, technical specifications, performance indicators, etc.
- Production and quality control information: including production process, quality management system certification (such as ISO standards), inspection reports, etc.
- Safety and performance verification information: Some categories may require verification reports or clinical trial information to prove that the product meets safety and performance requirements.
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