REGULATORY AUTHORITY: Ministry of Health (MoH)

CLASSIFICATION SYSTEM: Medical Devices/IVDs: Class A/B/C/D or 1/2/3

TIMEFRAME:

Actual timeline based on experience:

Medical Devices/IVDs Class A – 1 to 2 months

Medical Devices/IVDs Class B/C – 3 to 4 months

Medical Devices/IVDs Class D – 4 to 6 months

SPECIAL REQUIREMENTS:

On-site Audit: Not required.

Local Tests/Permit: May be required for some devices such as disposable sterile syringes, HIV test products, medical devices that contain/transmit radiation, medical devices that transmit radiofrequency/Bluetooth.

Local Clinical Evaluation or Studies: Not required.

LOCAL FEES (New Application):

Medical Devices/IVDs

Class A: USD 125

Class B/C: USD 225

Class D: USD 350

LOCAL FEELS (Manufacturer): No manufacturer registration is required. The local authorized representative, however, must be an establishment that holds a valid Medical Device Distributor License (MDDL) and implements a Good Distribution Practice of Medical Device (GDPMD).

LICENSE VALIDITY: Maximum 5 years (depending on the validity of authorization letter issued by the foreign manufacturer).

LICENSE TRANSFER: License transfer is possible but new registration is required.

AUTHORIZED REPRESENTATIVE:  A solely local authorized representative should be appointed by an overseas manufacturer through official Letter of Authorization (LoA).

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