Explain in detail the "CSDT" template requirements of ASEAN
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Explain in detail the "CSDT" template requirements of ASEAN
Views: 490 Author: Site Editor Publish Time: 2025-02-06 Origin: Site
Explain in detail the "CSDT" template requirements of ASEAN
CSDT document content
CSDT documents are similar to the requirements of other countries/regions, which require relevant information such as clinical evidence, design verification, risk analysis, labels and manufacturing information of the product. The ASEAN CSDT document contains the content of the Global Harmonization Task Force (GHTF) guidance document entitled "Summary T to Prove that it meets the basic principles of medical device safety and performance (Summary T Echnical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Perfor mance of Medical Devices, STED) (file number: SG1/N011R17) and International Medical Device Regulatory Forum (International Medical Device Regulato rs Forum, IMDRF) Non-In Vitro Diagnostic Device Market Authorization Table of Contents, NIVD MA ToC).As part of the CSDT application, the following documents are required.
1. General summary
Product overview, such as: descriptive information about the introduction of medical devices, the intended use and indications of medical devices, novel features and content summary of CSDT;
The history of commercial marketing;
The intended use and indications in the label;
List of regulatory approval or listing permits obtained;
The status in the request process;
Important safety/performance-related information.
Two. Relevant basic principles and methods used to prove conformity
3. Product description
Description and characteristics
Intended use
Instructions for use
Contraindications
Warning
Precautions
Potential adverse effects
Alternative therapy
Raw materials
Other related specifications
Other descriptive information
4. Summary of design verification and confirmation
List the published reports and conclusions related to the safety and performance of medical devices in accordance with basic principles;
Engineering test
Laboratory testing
Biocompatibility test
Animal experiments
Simulated use
Sensitivity
specificity
Precision
Accuracy
Verification of stability and so on
5. Preclinical data and clinical data, such as Clinical Evaluation Report (CER)
Software verification and confirmation research (if applicable).
Medical devices containing biological materials (if applicable)
Clinical evidence
6. Product label
Label sample
Instruction manual (IFU)
7. Risk analysis
8. Manufacturer's information
Production process
ISO 13485 certificate, etc.
The difference between STED and CSDT
International manufacturers usually need to submit application documents similar to one of the two main formats: STED or CSDT. STED represents a technical document summary, which was originally formulated by the Global Harmonization Task Force (GHTF) in 2011 and is now called IMDRF (International Medical Device Regulatory Authority Forum). STED has laid the foundation for the documents required by 5 major markets (also known as reference countries/regions). Reference countries/regions are nicknames for 5 major medical device markets, including the United States, Canada, the European Union, Japan and Australia. If the registration of one or more reference countries is approved, it can greatly help manufacturers obtain registration review faster in many secondary markets, so it is usually crucial to the registration process. Approvals of reference countries/regions are usually used as references because they are considered to show legitimate safety and effectiveness supervision.
Although STED and CSDT are similar in the overall topics of documents (such as basic principles, risk analysis and manufacturing processes), manufacturers should also pay attention to some subtle differences when writing documents.
The differences include:
Local language requirements: CSDT documents require more information, because many ASEAN member states have specific instruction manual (IFU) and label translation requirements, while reference countries/regions usually do not.
Summary: In some countries/regions (such as Indonesia and Vietnam), CSDT applications require a summary of the product, which may also be translated into a local language. Although the STED and CSDT formats will be different, the data used in the STED file can almost meet the requirements of CSDT, and other new data is rarely required.
