Medical Devices Registration in Philippines -

Introduction – Medical Devices Registration in Philippines

This article deals with the Medical Devices Registration in Philippines. The Philippines’ Food and Drug Administration (FDA), which functions under the Department of Health, issues the license, monitors, and regulates the flow of drugs, cosmetics and medical devices in Philippines. ASEAN Medical Device Directive (AMDD), released the list of documents needed for the registration of Medical Devices as per the classification.

Classification of medical devices in Phillipines

CLASS A – Low risk (e.g. bandages)
CLASS B – Moderate risk
CLASS C – Moderate/high risk
CLASS D – High risk (implantable defibrillators)

Agent

The foreign medical manufacturing company can have their own subsidiary, or can appoint their distributor, or through a third party in-country representative can register their Medical devices in Philippines.

Process

The document requirement list released aligns with the Philippines’ Common Submission Dossier Template (CSDT). The classification rules will be based on the ASEAN Medical Device Directive (AMDD) in future. Time Frames for registration vary from 3 to 6 months to get notification and registration Certification. The ISO 13485: 2016 Certification must be renewed annually. The Registration certifications are valid for 5 years.

CLASS A – All Class A devices must apply for the Certificate of Medical Device Notification (CMDN). The application must be submitted for notification. The Philippines FDA reviews the application and if approved, a notification number will be issued to the device. On submission of accurate documents a notification number will be issued to the device and the applicant is approved for the CMDN. Documents required for the CMDN application:

Notarized e-copy affidavit
Notarized application form
FDA issues a photocopy of the valid License to Operate in the Philippines.
Proof of payment or order of payment
An authenticated Certificate is issued by Philippine consulate for the importer and the Certificate of Agreement between the Manufacturer and Distributor is issued for Distributors.
Certificate attesting the status of the Manufacturer‘s competency and reliability of the personnel and facilities or Quality Systems Certificate of approval or compliance certificate with ISO 9000 series or ISO 13485 is issued by the Government.
Certificate of Product Notification or Certificate of Product Registration or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency/ which is accredited in the country of origin and authenticated by the territorial Philippine Consulate. Free sale certificates will not be accepted.
Should share sample or commercial presentation of the product, if needed, a color picture of the device
In accordance with the CSDT of the AMDD Technical requirements to be shared.
Intended use
List of all raw materials
Technical specification of the finished product
Reference codes, sizes, colors, models and variance, list to be shared.
Sterilization method and sterility test done on the device
Certificate of conformity to the aspect of manufacturer relating to metrology for devices with measuring functions
Declaration of conformity (self-declaration by the manufacturer) with product standards, if applicable
IFU and Sample of labels and other labeling materials to be used for the device to be shared,
Stability studies of the product to justify claimed shelf life, if applicable

Class B, C, D – All medical devices under this class must apply for a Certificate of Medical Device Registration (CMDR). The dossier is prepared and an application is submitted (CSDT format) for registration. The FDA Philippines reviews the application dossier and supporting documents, if further information is requested, the applicant must submit answers addressing the supplementary questions. If all the documents are accurate, the applicant is approved for a CMDR. The documents required are as follows –

National Legal Requirements:
Notarized e-copy affidavit
Notarized application form
FDA issues a photocopy of the valid License to Operate in the Philippines.
Proof of payment or order of payment
For distributors, the Certificate of Agreement between the Manufacturer and Distributor regarding the device; for imported medical devices, the Philippine consulate must appropriately authenticate the Certificate
Certificate attesting the status of the Manufacturer‘s competency and reliability of the personnel and facilities or Quality Systems Certificate of approval or compliance certificate with ISO 9000 series or ISO 13485 is issued by the Government.
Representative sample or commercial presentation of the product, when needed, and colored picture of the device
CSDT of the AMDD:Technical requirements
Executive summary
Essential principles and method/s used to demonstrate conformity,
Device description (including intended use, warnings, precautions, potential adverse effects, etc)
Summary of design verification and validation documents.
Physical Manufacturer information:
Manufacturing process, including quality assurance measures
A brief summary of the sterilization method

Fees –

The government fees include –

Class	Risk Type	Fee
Class A Notification (CMDN)	Low	PhP 7,500
Class B Notification (CMDR)	Low – Moderate	PhP 7,500
Class C Notification (CMDR)	Moderate – High	PhP 7,500
Class D Notification (CMDR)	High	PhP 7,500

Importation

The import duty on medical equipment is charged as per the rates prevalent at that time plus a value-added tax (VAT). The Philippines participates in the ASEAN Medical Device Regulatory Harmonization to improve and standardize the medical device regulatory process in the region. The LTO and the CPR are the 2 documents required from the company importing medical devices. A certificate of listing will be issued prior to the importation of the device that is for registration, for exempted medical devices. Prior to its implementation these new requirements will be coordinated with the Bureau of Customs.

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Medical Devices Registration in Philippines