ASEAN Common Submission Dossier Template (CSDT) is a common template for medical device manufacturers intending to venture into the ASEAN markets. The device information to be submitted to the Regulatory Authorities along with the application form shall be presented in the ASEAN CSDT format.
What is the Regulatory Basis and History of the CSDT?
The ASEAN Common Submission Dossier Template is suggested in Annex 4 of the ASEAN Medical Device Directive (AMDD), which is signed by the ten (10) countries of ASEAN region. The CSDT is intended to harmonize the information submitted for pre-market registration of medical devices and to ease the technical documentation activities for manufacturers intending to enter multiple ASEAN countries. This template is the ASEAN counter part of International Medical Device Regulatory Forum’s (IMDRF) Summary Technical Documentation (STED).
Which Products can use the CSDT Template for Pre-market Registration Purposes?
The CSDT template is applicable to general medical devices and Class B, Class C & Class D In-Vitro Diagnostic medical devices.
What are the Language Requirements for CSDT?
AMDD requires the CSDT technical documentation to be presented in English unless the ASEAN Member State (AMS) require it in any other language.
What are the Different Elements of CSDT?
Below listed are the key elements of a device CSDT technical file -
- Executive summary
- Essential principles and methods used to demonstrate conformity
- Device description
- Summary of design verification and validation
- Preclinical and clinical data (if necessary)
- Device labeling
- Risk analysis
- Manufacturer information – shall include details of manufacturing information, QA measures, and sterilization methods
What Information Shall Be Included in the CSDT Technical File?
The CSDT technical file shall include the below information for a given device –
- Introductory descriptive information on the medical device, the intended use and indications for use of the device
- Information on the use of the device, if any, such as targeted patient population, user profile (e.g., specific trained users), specific disease status or clinical condition (e e.g., continuous monitoring in critically ill patients), mode of action (e.g., absorption profile) etc
- If the medical device has any unique or novel feature or characteristic (e.g., nanotechnology, incorporates animal or microbial cells or tissues), a description must be provided
- Any high-level background information or details that the product owner wishes to highlight in relation to the device, its history or relation to other approved devices (e.g., predicate devices) or previous submissions (provides context to submission)
- Marketing history of the device
- Registration status (i.e., submitted, not submitted, pending, approval, rejected or withdrawn) and approved intended use and indications of the medical device
- Copies of approval letter(s) from each reference Agency. For CE marked devices, the EU declaration of conformity by the product owner must be submitted, in addition to the EC certificate issued by the Notified Bodies
- A summary of reportable Adverse Events (AEs) and Field Safety Corrective Actions (FSCAs) for the medical device, since its first introduction on the global market
- For FSCAs that are ‘open’, provide a description of any analysis and/or corrective and preventive actions undertaken by the product owner
- If there have been no adverse events or FSCAs to date, provide an attestation from product owner on the company letterhead, that there have been no adverse events or FSCAs, since commercial introduction of the device globally
- Essential Principles conformity checklist (EP checklist)
- Declaration of Conformity (DOC)
- List the standards that have been complied within the design and manufacturing (including sterilization) of the device
Medical device or IVD manufactures willing to access the ASEAN markets must be aware of the CSDT format for error-free Regulatory submissions. For more information on the ASEAN Medical Device Directives (AMDD), CSDT or device/IVD registration process in the ASEAN markets, consult a Regulatory expert.