REGULATORY AUTHORITY: Ministry of Health (MoH)
CLASSIFICATION SYSTEM: Medical Devices/IVDs: Class A/B/C/D or 1/2/3
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
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):
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).