Technical Terms

I Company No.: 1135238-U I Company No.: 1135238-U TECHNICAL GLOSSARY Computerised tomography, a diagnostic imaging technology that combines multiple X Ray projections taken from different angles to produce cross-sectional images of areas inside the body “CArm” Imaging scanner intensifier used primarily for fluoroscopic imaging during surgical, orthopedic, critical care, and emergency care procedures “CR” Computed radiography, a diagnostic imaging technology that digitises images produce in medical imaging devices such as X-Ray machines “distributor” A distributor refers to an appointed party (via a distributive agreement and/or letter of appointment) by manufacturer(s) to distribute products to third parties including suppliers, trading companies and/or end-users “Establishment License” A license granted under the MDA Act to an establishment carrying on business or practice principally in Malaysia who is a manufacturer, authorised representative of manufacturer, importer or distributor and is responsible for placing any medical device in the market with a view to distribute, use, supply or putting it into service “GDPMD” Good Distribution Practice for Medical Devices sets out the requirements for a quality management system to be established, implemented and maintained by an establishment (as defined under the MDA Act) in carrying out activities in the medical device supply-chain to comply with Malaysian medical device regulatory requirements, as stipulated in the MDA Act and MDR Act. GDPMD requires an establishment to demonstrate its ability to maintain quality, safety and performance of medical devices in compliance with the Malaysian medical device regulatory requirements throughout the supply-chain, which include, but not limited to, product sourcing and procurement, transportation and delivery, storage, installation, commissioning, service and maintenance, calibration of medical devices at the point of use and after sales service, tracking, documentation and record-keeping practices “Instrument cleaning Instrument cleaning chemistries and disinfectants are used for chemistries and cleaning, decontamination and sterilisation of surgical instruments. disinfectant” They can be used manually and in automated washers/ disinfectors and ultrasonic cleaners
\\IT” Information technology
“IVD” In-vitro diagnostics, is a method of performing a diagnostic test outside of a living body “MDA” Medical Device Authority, MOH “MDA Act” Medical Devices Act, 2012, the legislation providing the framework for the registration of medical devices in Malaysia xii [ Company No.: 1135238-U I
TECHNICAL GLOSSARY (Cont’d) “MDR Act” “MRI” “OEM” “QMS” “RFID” “supplier” “Washers/Disinfectors” “X Ray” Medical Devices Regulation, 2012, the regulation governing the registration of medical devices in Malaysia Magnetic resonance imaging, a diagnostic imaging technology that uses radio waves and a magnetic field to create detailed images of tissues and organs Original equipment manufacturer Quality management system Radio-frequency identification, commonly utilised for sorting and organising A supplier refers to a party that obtains the supply of products from manufacturer(s) or distributor(s) for subsequent sales to third parties including other suppliers, trading companies and/or end-users Washers/disinfectors are used in the cleaning of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments (i.e. forceps and clamps), theatre shoes and other similar and related items found in healthcare facilities A electromagnetic wave utilised in amongst others, medical imaging and diagnostic imaging technology
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