Philippines Medical Device Registration : Regulations, Market Insights, and Compliance Guidelines

Introduction to the Philippines Healthcare Market

The healthcare market of the Philippines has a high degree of dependence on imports. Almost 100 percent of all medical equipment as well as over 65 percent of medical disposables are imported. There are no significant manufacturing facilities; only gloves, syringes, needles, hospital beds, and hospital furniture are manufactured locally.

Popular imported medical equipment includes incubators, x ray systems, anesthesia systems, fetal monitors, autoclaves, and sterilizers. The list of imported medical devices includes orthopedic devices, stents, catheters, syringes, wound healing devices, and dental implants.

This high degree of import dependency emphasizes the need for Philippines medical device registration for companies interested in accessing the healthcare market.

FDA Regulations for Medical Devices - Philippines

The FDA Philippines (Department of Health) is responsible for regulating the drug, cosmetics, and medical devices. Registration is done in accordance with the ASEAN Medical Device Directive which provides information about the criteria for classifying medical devices in the Philippines.

Medical Device Classification under FDA Philippines

1. Class A - Low risk devices (e.g., bandages)

2. Class B - Medium risk devices

3. Class C - Medium/high risk devices

4. Class D - High risk devices (e.g., implantable defibrillators)

It is important to know the FDA Philippines medical device classification of the device to determine the correct procedure to be followed in registering it.

Healthcare Demand Context in the Philippines Medical Equipment Market

Private hospitals make up the major portion of the healthcare system in the Philippines, whereas the public healthcare system holds a minor share. The former purchases new as well as second hand medical devices, while the latter buys only new medical devices. It directly affects the importation and registration of the devices, thus stressing the significance of medical device registration in the Philippines.

Appointing a Distributor or Agent for  Philippines 

Foreign medical device manufacturers can register their products by:

• Establishing a subsidiary in the Philippines,

• Partnering with a local distributor, or

• Appointing a third party as a country representative.

Role of Local Distributors in FDA Medical Device Registration

Hospital considerations include:

• The international prestige of the manufacturers,

• The availability of local distributors who can provide services after the purchase,

• Price competitiveness,

• Guarantees on services, and

• Staff training program.

Procurement processes are usually conducted during the third and fourth quarters of the year because both private and government hospitals make their requirements for the year.

CMDN and CMDR Process for Medical Device Registration in Philippines

Submissions should conform to the Common Submission Dossier Template (CSDT). The approval process takes about 3 to 6 months, and the registration period is 5 years. ISO 13485:2016 certification should be renewed yearly according to Philippines medical device regulations.

Class A  Certificate of Medical Device Notification (CMDN)

• It is mandatory for all Class A medical devices. The application should contain the following:

• Affidavit and application form,

• License to Operate (LTO),

• Payment proof,

• Manufacturer-distributor agreement (stamped by the Philippine consulate),

• ISO 13485 certification,

• Certification of product safety/effectiveness (from the country of origin - free sale certificates are not accepted),

• IFU, labeling samples in accordance with national requirements, stability data (if required), and sterilization data.

Class B, C, D  Certificate of Medical Device Registration (CMDR)

Mandatory requirement for high risk classes. Apart from those listed above, dossiers shall contain:

• Executive summary,

• Description of the device (intended use, warnings, precautions, adverse effects),

• Essential principles and conformity documentation,

• Summary of design verification and validation activities,

• Manufacturing process and quality assurance,

• Sterilization technique.

CMDN and CMDR should be accompanied by a complete set of documentation that consists of affidavits, LTO, ISO 13485 certificates, safety/effectiveness information, and compliance with labeling requirements for medical devices Philippines.

Philippines FDA medical device regulatory system provides for the evaluation of safety and quality of devices prior to marketing authorization.

New Expedited Pathway for FDA Philippines Medical Device Registration

The Philippines FDA issued a new circular in February 2023, providing for an abbreviated registration procedure for Class B, C, and D devices according to the existing regulations for medical devices in the Philippines.

• The abbreviated procedure can be used in cases where devices have been approved by the National Regulatory Authority (NRA) of any ASEAN member state in accordance with AMDD CSDT criteria.

• CDRRHR of the FDA expedites these applications according to the principle of reliance, greatly decreasing the time of their evaluation.

• Applicants shall prove that technical specifications provided to the FDA are the same as the ones provided to the reference NRA.

• FDA has the right to deny abbreviated approval in cases if:

• There are negative reports from other countries;

• There are different views of ASEAN; or

• Extra review is required.

• Labeling shall be considered according to AO No. 2018-0002 in order to make sure that they meet requirements for medical device labeling in the Philippines, and proof of payment shall be attached to the application.

This policy is designed to streamline market entry for innovative and life-saving devices, while ensuring safety through reliance on trusted ASEAN regulatory approvals.

Market Insight  Medical Equipment and Devices in High Demand

Commonly imported items that require CMDN/CMDR include:

• Catheters, needles, syringes, sutures,

• Orthopedic and dental implants,

• Imaging systems (X-ray, MRI, ultrasound),

• Wound healing items,

• Surgical equipment and diagnostics.

The above are the main types of items which need Philippine medical device registration in order to meet all the requirements. Documentation prepared in advance may assist in simplifying the medical device registration in the Philippines process.

FDA Fees Charged by the Philippines Government for Classifying Philippines Medical Devices

• Class A (CMDN): PhP 7,500

• Class B (CMDR): PhP 7,500

• Class C (CMDR): PhP 7,500

• Class D (CMDR): PhP 7,500

Global Supply Map

The main supplying nations to the Philippines are:

• USA – 29%

• Germany – 18%

• Japan – 16%

• Singapore – 12%

• Others – 25%

The major international players in this market are GE, Siemens, Hitachi, Smith & Nephew, Fujirebio, Varian, and American Orthopedic. This is an indication that the market share is held by these firms.

Import Regulations and Licensing for Medical Devices

Importation of medical equipment is taxable through customs duties and VAT.

As an ASEAN member state, the country follows closely the Philippines medical device regulation guidelines.

Authorizations Required

• License to Operate (LTO): Necessary for importers, distributors, manufacturers, traders, or wholesalers.

• Certificate of Product Registration (CPR): Obtained after the successful completion of the comprehensive: Philippines medical device registration process.

Following the classification of medical devices in the Philippines will ensure customs clearance and avoid legal actions on non-notified products.

FDA Action Against Products Without Notification Certificate 

FDA Philippines has enforced strong warnings regarding the acquisition and use of medical devices that were not notified. As per Republic Act 9711 (Food and Drug Administration Act of 2009), it is an offense to put into commerce any product related to health care if it was not evaluated and approved by FDA.

Here are the recent products found to be in violation:

• Band Doctor: 25mmx60mmX6, 38mmx60mmX2, 38mmx38mmX2, 41mmx72mmX8

• Band Care: 19mmx72mmX12, 38mmx38mmX2, 10mmx40mmX6, 38mmx72mmX2

These products are being sold in the market without the Certificate of Medical Device Notification (CMDN).

Since unnotified products are not subjected to regulation, there is no guarantee that these products comply with safety and quality standards, as well as labeling requirements of medical devices in the Philippines.

It is hereby ordered that all establishments stop the distribution, marketing and sale of these products until the products obtain the required notification certificate.

Healthcare professionals, distributors, and consumers are advised to:

• Make sure that a product is labeled with a proper FDA notification number (CMDN-xxx) as required by the medical device labeling regulations in the Philippines.

• Make use of FDA’s integrated online system search at www.fda.gov.ph for checking the product’s notification status based on the classification of medical devices in the Philippines.

• Report any unnotified devices using the FDA’s e-report system or contact FDA CDRRHR directly.

The Bureau of Customs, LGU’s and other law enforcement agencies have been asked to prevent the import and sales of such devices.

This shows that compliance to CMDN/CMDR requirements is very important in order to make sure that safe and notified products enter into the Philippines' market.

Philippines FDA Medical Device Guidelines During Public Health Emergencies

There are guidelines set by the FDA Philippines in regulating medical devices during public health emergencies. Public health emergencies may include:

• Bioterrorism,

• Emergence of a new or existing infectious agent,

• Natural disasters,

• Chemical warfare, or

• Nuclear warfare.

PFDA Emergency Response Process Flow for Philippines Medical Device Registration 

• Within 24 hours after declaring the emergency, the FDA Director General calls the PFDA Crisis Management Committee together and puts up a task force.

• Regulatory guidelines should be issued within 15 days and maintained throughout the period of the emergency.

• Budgetary considerations are put up by the Director General to make sure of the efficient allocation of resources.

• Coordinating with internal and external parties becomes the responsibility of the task force for efficient communication.

• Updates and recommendations are given to the Director General by the PFDA Crisis Management Committee.

• The FDA Director General makes a report to the DOH Secretary and PFDA President.

Such efforts are made to make sure that regulatory guidelines for medical devices can be amended easily and efficiently during emergencies.

Conclusion

There is high potential of the Philippines market for foreign medical device manufacturers as it relies heavily on imports and faces an increasing demand from private hospitals.

To be successful in this market, one should take care of the following aspects:

• Regulatory requirements fulfillment:  by way of CMDN/CMDR registration, LTO, and CPR.

• Market access: through successful collaboration with local distributors, knowledge of the purchasing process and competitive positioning among other international leaders.

Morulaa HealthTech can offer you professional support in registering and entering the Philippines medical devices market.