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MDA Classification

Classification Guidance

Medical Device Classification Guidance
MalaysiaMedical Device AuthorityClassificationEffective 2020
What this code is

Classification Guidance is the official MDA identifier for “Medical Device Classification Guidance”. Classification Guidance is the official identifier MDA uses for this instrument.

Instrument
Classification
Full name
Classification Guidance
Category
Classification
Source links
Authority source
English
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
Not available yet
Use the official source while a readable HTML version is being prepared.
Dates
Published
2020
Effective
2020
About this regulation

Medical Device Classification Guidance

Malaysia uses ASEAN-aligned risk-based classification: Class A (low risk), Class B (low-moderate), Class C (moderate-high), Class D (high risk). Classification determines registration pathway.

Classification Guidance is the official identifier MDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.