APPLICATIONS
Medical device
A medical device cleanroom in Malaysia is usually ISO 7 or ISO 8, sized by the device class and how the product is finally sterilised.
TYPICAL CLASSIFICATION
Assembly and primary packing typically run at ISO 7. Secondary packing often sits at ISO 8. See the full ISO 14644 limits →
WHAT THE ROOM HAS TO SATISFY
What actually sets the class
What sets the class here is how the product is finally sterilised and how much of it is exposed on the line, not the device category on its own. In vitro diagnostic manufacturing adds a humidity requirement that reagent handling drives harder than the particle count does. The quality control and microbiology laboratories sit alongside production but need a transfer route that does not run through it.
REGULATORY CONTEXT
- Medical devices in Malaysia are regulated by the Medical Device Authority under the Medical Device Act 2012.
- Manufacturers are commonly assessed against ISO 13485, which requires the work environment to be controlled where product conformity depends on it.
- Establishments involved in distribution are separately assessed under GDPMD.
- Your facility documentation is part of the conformity assessment file, so the room and the registration are one workstream, not two.
WHAT WE SUPPLY
What we supply
- ISO 7 and ISO 8 room systems
- Gowning and airlock sequences
- Pass boxes and material transfer
- Classification and monitoring documentation
Send your floor plan and target class. Request a site assessment →