REGULATORY AUTHORITY: Medical Device Authority (MDA)

CLASSIFICATION SYSTEM: Medical Devices and IVDs: A/B/C/D

TIMEFRAME:

Medical Devices and IVDs (official timeline excluding timeline for CAB review):

Class A – 45 working days

Class B – 100 working days

Class C – 180 working days

Class D – 220 working days

SPECIAL REQUIREMENTS: Not applicable. However, it is very unlikely that during the QMS assessment stage, the Conformity Assessment Body (CAB) will consider any relevant existing certification of the manufacturer and, if it is not satisfying, an on-site audit to the manufacturer’s facility might be necessary to be carried out.

LOCAL FEES (New Application):

MD/IVD Class A – USD 24

MD/IVD Class B – USD 300

MD/IVD Class C – USD 600

MD/IVD Class D – USD 900

*these are fees charged by MDA (excluding charge for CAB review).

LOCAL FEES (Manufacturer): Foreign manufacturer registration is not required but every establishment (either AR, importer, or distributor) who is dealing with medical devices must apply for the establishment license.

LICENSE VALIDITY: 5 years.

LICENSE TRANSFER: License transfer process is possible through a process called “Change of Ownership”.

AUTHORIZED REPRESENTATIVE: The foreign manufacturer should appoint the authorized representative to act on behalf of the manufacturer and to act as the license holder.

ADDITIONAL INFORMATION:  Medical devices that have never undergone assessment and approval for placement in the market of recognized countries will undergo full assessment procedure (validation). While medical devices that have been approved and marketed in the recognized countries (such as Australia, Canada, EU, Japan, United States, and United Kingdom) will undergo verification/assessment process (recognition procedure).

Other Southeast Asian Countries: Cambodia, Indonesia, Myanmar, Philippines, Singapore, Thailand, Vietnam