REGULATORY AUTHORITY: Centre for Device Regulation, Radiation Health, and Research (CDRRHR)
CLASSIFICATION SYSTEM: Medical Devices and IVDs: A/B/C/D
TIMEFRAME:
(According to our experience)
Class A: 1-2 months
Class B/C/D: 6-9 months
SPECIAL REQUIREMENTS:
Local test is only required for devices with radiofrequency radiation, measuring function, and drug screening test kits and reagents. Certain registrable IVD devices such as pregnancy test kits using urine specimen, HIV testing kit, COVID-19 test kits and reagents are also subject to a local laboratory testing.
Local clinical evaluation or studies is not required.
LOCAL FEES (New Application):
New registration:
For registrable devices (medical device class A/B/C/D) – USD 156
For non-registrable devices (medical device class B/C/D) – USD 62
IVD – USD 32 (additional USD 22 for pregnancy kit)
LOCAL FEES (Manufacturer): N/A
LICENSE VALIDITY: Certificate of Medical Device Notification (CMDN) and Certificate of Medical Device Registration (CMDR) for registrable medical device is valid for 5 years.
Certificate of Medical Device Notification (CMDN) for non-registrable medical device is valid for 2 years.
LICENSE TRANSFER: License transfer or change of license ownership is considered as a variation.
AUTHORIZED REPRESENTATIVE: A foreign manufacturer must appoint a company with valid License to Operate (LTO) to become their authorized representative.
ADDITIONAL INFORMATION:
April 2022 – Certificate of Exemption (COE) is no longer valid and the importation without CMDN is still allowed so long as the CMDN application for class B, C, and D non-registrable medical devices has been submitted.
April 2023 – FDA stops receiving CMDN applications for class B, C, and D non-registrable medical devices and approved CMDN for such devices must be converted to CMDR.
Specific list of registrable IVDs (including COVID-19 test kits and reagents) shall undergo a product registration and a local testing will be required.
An abridged registration process was introduced in November 2021. This is only applicable for class B, C, D devices that have obtained approval from ASEAN member countries that have implemented CSDT such as Singapore and Malaysia.
