CLMA Pharmaceutical

Medical Device Registration

Registering a medical device with the FDA (Food and Drug Administration) in the Philippines involves several steps to ensure compliance with regulatory requirements. Here’s a detailed guide on the process:

1. Classification of Medical Device

The first step is to determine the classification of your medical device. The FDA classifies devices into four main categories based on risk:

Class A: Low risk
Class B: Low to moderate risk
Class C: Moderate to high risk
Class D: High risk

2. Pre-Market Approval (PMA)

For certain high-risk devices, you may need to obtain Pre-Market Approval. This involves a thorough review of the device’s safety and efficacy.

3. Local Agent

If you are a foreign manufacturer, you must appoint a local authorized representative or distributor who will act as the liaison with the FDA.

4. Submission of Requirements

Submit the following documents to the FDA:

Legal Documents

Application Form
Letter of Authorization (if applicable)
Valid Certificate of Product Registration (CPR) from the country of origin
ISO 13485 Certificate or equivalent Quality Management System certification
Free Sale Certificate (FSC) or Certificate to Foreign Government (CFG)
Notarized Deed of Undertaking

Technical Documents

Device description
Intended use
Instructions for use
Risk management file
Clinical evaluation/study reports
Labeling information

5. Payment of Fees

Pay the applicable fees as per the FDA’s fee schedule. The fees vary based on the class of the medical device.

6. Evaluation Process

The FDA will evaluate the submitted documents. This process involves both administrative and technical review.

7. Issuance of Certificate of Product Registration (CPR)

If the FDA finds the application satisfactory, they will issue a Certificate of Product Registration (CPR). This certificate is valid for a specific period, usually five years, and must be renewed before expiration.

8. Payment of Fees