Understanding the Medical Device Registration in Philippines

Regulatory Authority

Center for Device Regulation, Radiation Health and Research (CDRRHR)

The Food and Drug Administration, established under Republic Act No. 3720, series of 1963, and later amended by Executive Order 175, series of 1987, is a regulatory agency under the Department of Health. Its mandate is to ensure the safety, efficacy, and quality of health products such as food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, radiation-emitting devices, household/urban hazardous substances, pesticides, toys, and consumer products that may affect health.

Link for Regulatory Authority

https://www.fda.gov.ph/

Local Regulation 

Administrative Order 2018-0002

Classification of Medical Devices 

Class A, B, C and D

Listing or Registration Requirements

• Medical devices manufacturers may not import, export, manufacture, distribute or market their products in the Philippines, unless they are notified or registered with the FDA, depending on the device risk classification.
• Class A devices must be notified and consequently the Regulatory Authority issues the Certificate of Medical Device Notification (CMDN).
• Class B, C and D devices must be registered with FDA, following which the Certificate of Medical Device Registration (CMDR) will be issued.

Documents Required for Philippines Medical Device Registration

• ISO 13485
• Free Sale Certificate from Country of Origin
• Device description, features, indications
• Instructions for Use
• Pre-clinical Studies
• Clinical Studies
• Shelf Life and Biocompatibility
• Label
• Risk Analysis
• Manufacturing Process

Registration Timeline

Time taken to obtain approval on submission of dossier is 6-9 months with a validity of 1 or 5 years.

Registration Fee 

Fee details.

License Validity

5 Years

License Renewal

Renewals can be filed 90 days prior to the expiry of the CMDR or CMDN.

Special Labelling Requirements

Labeling shall be provided in English

Additional Comments 

Documentation shall be provided in English

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the Process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk