TR-02
TR-02 is the official HSA identifier for “Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT”. TR-02 is the official identifier HSA uses for this instrument.
- Instrument
- TR-02
- Full name
- TR-02
- Category
- Registration
- Authority source
- English
- Readable HTML
- 32 articles · 1 language version
- Published
- March 2024
- Effective
- —
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Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT
HSA TR-02 Revision 3 (March 2024). Technical reference detailing the contents of each CSDT section for IVD medical devices. Ingested as sec-1 through sec-5 with four-level clauses preserved (sec-4-3-2-1 bibliography).
TR-02 is the official identifier HSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.