Updated October 2019
Procurement & Tenders
Population: 106 million
GDP: $313.6 billion
Currency: Philippine Peso (PhP)
Language: Filipino (official; based on Tagalog) and English (official)
The Philippine medical equipment market remains lucrative for U.S. suppliers. Highly dependent on imports, the market continues to expand at a steady pace. Medical equipment is almost 100% imported, as are approximately 50% of medical disposables. Local production is limited to prototype units, spare parts (including improvised parts), and disposables such as surgical gloves, syringes, and needles.
Market demand is driven by the private sector, where four major hospital developers – St. Luke’s Medical Center (SLMC), Metro Pacific Investments Corporation (MPIC), QualiMed Health Network (Qualimed), and Mt. Grace Hospitals, Inc. (MGHI) – continue to expand through acquisitions of existing facilities (MPIC and MGHI) and through construction/development of new hospital projects (Qualimed).
Major factors impacting demand are population growth, steady economic growth at 6% average, and hospital expansion and upgrading.
Official Department of Health (DOH) statistics indicate that there are about 1,800 licensed hospitals in the country, of which about 60% are privately owned. Total bed capacity is about 100,000. Hospitals base buying decisions on price and quality.
Achieving full coverage to quality health is an objective of the current administration. To date, more than 94% of Filipinos are covered by social health insurance through the Philippine Health Insurance (PhilHealth).
Buyer preference for U.S.-manufactured equipment is justified by product technology and quality, access to warranty parts and services, and available training for equipment handling. However, U.S. brands face increasing third-country competition from China, Germany, Singapore, and South Korea.
The market is price-sensitive, which explains the growing presence of inexpensive equipment from China or South Korea. Hospitals with limited budgets source medical equipment from these countries.
The import duty on medical equipment is 3%, plus a 12% value-added tax (VAT). The Philippines participates in the ASEAN Medical Device Regulatory Harmonization Workshop. The workshop is part of an ongoing initiative to improve and standardize the medical device regulatory process in the region. Its ultimate objective is to facilitate the regulatory process for medical device registration in ASEAN member countries.
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U.S. suppliers interested in selling in the Philippines should appoint a local distributor who will handle all aspects of importation including registration, obtaining a license, and getting customs clearance for the products. The local distributor not only helps facilitate the product's entry into the market, but also assumes responsibility for advertising and promotion through sales and dealer networks. The local distributor registers with the Food & Drug Authority (FDA) before operating and receives a License to Import and a License to Operate (LTO) from the FDA.
CS Philippines can connect U.S. companies to Philippine distributors who are licensed and accredited by the Philippine FDA, and who have a nationwide sales and marketing network.
The average tariff rate for Medical equipment is 3% plus a 12% value-added tax (VAT). The VAT is based on the valuation determined by the Bureau of Customs for the application of customs duties, plus those duties themselves, excise taxes, and other charges (i.e., charges on imports prior to release from customs custody, demurrage fees, including insurance and commissions). The Bureau of Customs (BOC) is responsible for customs valuation, classification, and clearance functions.
Current Market Trends
Public hospitals tend to place a greater emphasis on preventive healthcare, while private hospitals concentrate on curative services. Private hospitals are equipped with more sophisticated medical equipment due to higher budgets. Middle to upper-class citizens predominantly use private healthcare services, while lower middle- to lower-class citizens typically consult with public health practitioners and go to public hospitals.
The Philippines’ Department of Health lists the following diseases with growing incidence rates: hypertension and heart diseases, diabetes and kidney failure, pulmonary and other respiratory diseases, cancer, HIV and AIDS. Most hospital improvements concentrate on specialized services for radiology, cardiac, lung and kidney examinations, and pathology to address the problem. Hospitals enhance their pathology services to meet demands for various diagnostic testing, especially for diabetes, cancer, and HIV/AIDS. Demand for ECGs, CT Scans, X-ray machines, dialysis machines, and other laboratory instruments remain, while dermatology services and clinical aesthetics procedures continue to grow.
The U.S. performs well with high-value, low-volume medical equipment such as ultrasound equipment, magnetic resonance imaging (MRI) equipment, breathing equipment, and other radiology and electronic medical equipment. U.S. manufacturers continue to face increasing competition from third country suppliers such as China, Germany, Singapore, and Korea.
In total, there are approximately 1800 hospitals in the Philippines, of which 721 (40%) are public hospitals; the DOH directly operates 70 of them.
The Philippines has made significant investments and advances in health in recent years. Rapid economic growth and strong country capacity have contributed to Filipinos living longer and healthier lives. However, not all the benefits of this growth have reached the most vulnerable groups, and the health system remains fragmented. National health insurance now covers more than 94% of the population. The goal is 100% coverage.
Current demand reflects healthcare requirements for growing incidences of hypertension, diabetes/kidney diseases, TB/respiratory ailments, cancer, and some incidence of HIV/AIDS. Products with high sales potential for U.S. suppliers include electro-cardiographs, computed tomography apparatus (CT scan), magnetic resonance imaging (MRI) equipment, ultrasonic scanning machines (ultrasound), X-ray and radiation equipment, breathing appliances, and linear accelerators. Demand for diagnostic laboratory products, supplies, and biological rapid test kits also exists.
Requirements for efficient healthcare services, new technology, and equipment replacement drive market growth. All hospitals must continue upgrading facilities to remain competitive.
Developments in the market continue to present opportunities for U.S. manufacturers and distributors of high-value, low-volume products of the latest technology and highest quality, such as electro-medical devices, imaging equipment, radiation equipment, dialysis devices, and linear accelerators.
The current administration is keen on pushing for the deployment of more doctors in the Philippine countryside, and to provide them with better pay to ensure better health for most Filipinos. The increasing demand for health services is not being met by the current number of health facilities and medical workers. The government plans to build more health facilities in the countryside and train or hire more healthcare professionals.
Medical device distributors expect 5-10% growth through 2020.
Foreign suppliers usually appoint a licensed distributor to represent their interests in the Philippines. Distributors handle all aspects of importation, including product registration. Distributors assume responsibility for a medical device’s capability, safety, market performance, and after-sales service; thus, they prefer exclusive contracts with foreign suppliers.
The Center for Device Regulation, Radiation Health and Research (CDRRHR) under the Philippine Food and Drug Administration (FDA), oversees the regulation of medical devices/equipment.
A foreign company must provide complete documentation for its medical device to the distributor who will register them. Complete and correct documentation determines the outcome of registration, and the length of registration process.
U.S. medical companies had complained of a serious backlog in the registration of products at the CCDDRH/FDA, so that when an opportunity to meet the FDA leadership came up, the U.S. Commercial Service office in the Philippines collected inputs from stakeholders to discuss with the local FDA leadership.
In June 2019, U.S. Commercial Service Philippines raised the issues of back-log and registration issues with the Philippine FDA’s Acting Director General (A/DG), who acknowledged that there was a lot of backlog and that he was working on hiring staff who could handle renewals, so that more senior staff could handle the complicated registrations or new products, and diminish some of the backlog. The A/DG is more committed to making the new FDA more transparent and efficient.
In January 2018, the Philippine Department of Health (DOH) approved and released Administrative Order (AO) No. 2018-0002, i.e. “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” (http://www.asiaactual.com/wp-content/uploads/2018/01/AO-2018-002-Medical-Device-Registration-Requirement.pdf). The new AO provides guidelines on the documentary requirements for the registration of medical devices and aligns the registration requirements to the Common Submission Dossier Template (CSDT) based on the provisions of the ASEAN Medical Device Directive. The new requirements will apply to all medical devices to be sold, imported, manufactured, or used in the Philippines. This new AO will take effect in March 2019. In the meantime, the CDRRHR issues a Certificate of Registration (CPR) upon completion of assessment of a medical product. The average timeline for a CPR is 180 calendar days.
The CDRRHR also issues a Certificate of Exemption (COE) for medical devices that were not classified as “registrable,” prior to the implementation of AO 2018-0002. The COE is voluntary, and usually requested by firms that wish to facilitate release of shipment from Customs, or to participate in bids. The requirements for the issuance of a Certificate of Exemption (COE) are:
The Philippine Health Insurance Corporation (Philhealth) is a tax-exempt government corporation attached to the Department of Health (DOH). It administers the National Health
Insurance Program, including the standards of health benefits for the citizens, formulates and implements guidelines on contributions and benefits, healthcare provider arrangements, payment methods, and referral systems.
The National Health Insurance Program was established to provide health insurance coverage and ensure affordable, acceptable, available and accessible healthcare services for all citizens of the Philippines. It serves as a channel to help pay or subsidize costs for the care of the sick. The program includes a system of funds collection, management, and financing of a basic minimum package and other supplementary packages of health insurance benefits by an expanding population and is limited to paying for the utilization of health services by covered beneficiaries.
The Universal Health Coverage (UHC) bill’s aim was to include all Filipinos in the National Health Insurance Program and grant them immediate eligibility to claim the benefits when needed. Philhealth revealed that over 100 million Filipinos are currently covered by PhilHealth. With UHC, the remaining six million of the population will soon be included and provided with health insurance. This means that more than 94% of Filipinos as already covered by Philhealth, closely inching toward its goal of 100% coverage.
As of November 2018, PhilHealth addressed 97.8% of the concerns routed through its hotline and reported a 95.65% resolution rate for inquiries logged via “Contact Center ng Bayan,” a local call center. Philhealth not only resolved complaints at a high clip, but also recorded the fastest turn-around-time.
Private health insurance coverage, or out of pocket (cash and credit card), is the usual means of payment for private healthcare services. Private health insurance is voluntary. Most private sector employers share in the payment of private health insurance of their employees. Coverage varies depending on agreement of employers and healthcare provider agencies.
There are no barriers to the sale or purchase of medical equipment of acceptable international standards. However, there are some policy changes that affect U.S. firms.
The newly approved DOH AO 2018-0002 will apply to all medical devices (and some consumer products typically not classified as medical devices) to be sold, imported, manufactured, or used in the Philippines, except in-vitro diagnostic and refurbished medical devices, which will be covered by separate AOs.
Prior to its approval, AO 2018-0002 was pending for several years, thus, most medical device companies are prepared and able to deal with the changes. However, the AO initially classified some consumer products (baby diapers, adult diapers, manual toothbrushes, and electric toothbrushes) as medical devices, triggering confusion among manufacturers/suppliers of these products. While baby diapers and manual toothbrushes have been removed from the medical device list through an FDA Memorandum, (which all hope is permanent) adult diapers and electric toothbrushes still will be classified as medical devices. Furthermore, the Government will not release a final list of products classified as medical devices and it will fall on each firm
to research and determine whether their product will fall into the medical device category in the Philippines. Firms that are unsure can apply to have their product classified.
Another AO awaiting approval from the DOH Secretary concerns the proposed fee increases for FDA licensing and registration and other services to stakeholders in the following sectors: Medical Devices, Pharmaceutical, Food and Beverage, Nutraceuticals, Herbal/Organic/Natural Products, Cosmetics, Food and Beverage, and Household Hazardous products (room sprays, deodorizers, other aerosol products). The industry has been expecting fee increases, since fees have not changed since 2001, and it is common knowledge that they need to be updated. The initially proposed draft of fees circulated to industry has included fee increases at over 500%, as well as the discrimination in fee structures between local and foreign manufacturers. This fee increase was among the issues that the U.S. Commercial Service in the Philippines raised at the meeting with the Acting Director General of the FDA. The latter commented that FDA first had to improve its services before raising fees.
A copy of the AO is available in the FDA website: https://ww2.fda.gov.ph/index.php/drafts-for-comments/514522-new-schedule-of-fees-and-charges-of-the-food-and-drug-administration-for-licensing-registration-and-other-authorizations-and-regulatory-services
Procurement and Tenders
The Philippine Government Electronic Procurement System or PHILGEPS is the single, centralized electronic portal that serves as the primary and definitive source of information on government procurement. The PHILGEPS website provides guidance on participating in a government bid. (https://www.philgeps.gov.ph/)
November 18-21, 2019 / Dusseldorf, Germany
Arab Health 2020
January 27-30, 2020 / Dubai, UAE
Florida International Medical Expo (FIME) 2020
June 23-25, 2020 / Miami Beach, FL https://www.fimeshow.com/en/home.html
American Association of Clinical Chemistry / Annual Meeting & Clinical Lab Expo 2020
Products with high sales potential for U.S. suppliers are high-value, low-volume, and high-tech products such as linear accelerators, electro-cardiographs, ultrasonic scanning machines (ultrasound), magnetic resonance imaging (MRI) equipment, dialysis devices, X-ray and radiation equipment, breathing appliances, and computed tomography apparatus (CT scan). Demand also exists for clinical laboratory devices, supplies, and biological rapid test kits.
1. How can U.S. companies sell their medical devices in the Philippines?
U.S. exporters may work through authorized distributors who have experience in handling importations, customs clearance, FDA registration, or directly with hospitals. The U.S. Commercial Service in the Philippines can assist exporters in meeting their objectives by introducing them to qualified potential distributors. These distributors are FDA licensed, and have been vetted by our office. We offer these through various programs of the U.S. Commercial Service, which are described in this link: www.export.gov/philippines. We also encourage companies to work with the Export Assistance Center (EAC) in their area, to obtain more information on best prospect markets for their products and on the basics of exporting. The EAC can coordinate with us and arrange conference calls as a first step to discuss potential market opportunities.
2. How long does it take to register medical devices?
Under the Philippine Department of Health (DOH) Administrative Order (AO) 2018-0002 (http://home2.doh.gov.ph/ais_public/aopdf/ao2018-0002(1).pdf), which was issued in January 2018, all medical devices, including ECG, EEG, and other imaging devices, which were considered non-registrable prior to the AO, need to now be classified and registered with the Philippine FDA. A.O. 2018-002 will be in full implementation in March 2019. Medical device companies have one year within which to register all previously exempted products. The Philippine FDA will issue a memo extending the number of registration applications allowed per week as this has been an on-going problem for firms. Limited registrations per week have resulted in significant backlog, and to ensure compliance with new policies, the agency will need to be able to process a huge volume of registrations expected to come in until 2019. They are also working on implementing an online application and facilitating payment procedures. Backlog and limited registration remain major concerns for industry as registrations can take anywhere from 6 to 18 months. Industry is open to increased fees for registration processes as long as registration can be expedited and handled in a timely and consistent manner.
3. What are the top hospitals that expand operations and provide opportunities for US medical device companies?
Metro Pacific Investments Corporation (MPIC), QualiMed Health Network (Qualimed), and Mt. Grace Hospitals, Inc. (MGHI) continue to expand through acquisitions of existing facilities (MPIC and MGHI) and through construction/development of new hospital projects (Qualimed). Two other hospital groups with two hospital facilities each – St. Luke’s Medical Center (SLMC) and The Medical City – are tertiary hospitals and are JCI-Accredited (https://www.jointcommissioninternational.org/). Two other JCI-accredited hospitals are MPIC’s Makati Medical Center and Cebu’s Chonghua Hospital.
Healthcare spending (including investment)
... as percent of GDP
Hospitals, Procedures, Healthcare Professionals UN:
Number of hospitals
……Private prepaid plans as a percentage of private expenditure on health
Number of hospital beds
... available beds per capita
1 bed/1,000 population
Life expectancy men/women
21.4/1000 live births
Percent of population older than 65
6.1 deaths/1000 people
…Leading causes of Death
Ischemic Heart Diseases; Neoplasms; Pneumonia; Cerebro-Vascular Diseases; Hypertensive Disease; Diabetes Mellitus; Other Heart Diseases; Respiratory; Tuberculosis; Chronic Lower Respiratory Infections; Diseases of the Genitourinary System
…Prevalence of HIV
912 new HIV cases documented in March 2018
U.S. Commercial Service Contact Information
Name: Dey Robles
Position: Commercial Specialist
Phone: (632) 301-2260
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