Medical Device Registration and Approval in Philippines

General country-specific regulatory information is provided on this page for medical device registration and approval in Philippines. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Philippines, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in the Philippines

 

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. 

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/LICENSE HOLDER: As of January 2021, non-registrable class B, C, and D medical devices are subject to obtain Certificate of Medical Device Notification (CMDN). Certificate of Exemption (COE) for such devices will only be valid until March 31st, 2022.

 

Last updated on May 03, 2021.

Other Southeast Asian Countries:

Cambodia, Indonesia, Malaysia, MyanmarSingapore, Thailand, Vietnam

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