Current Market Trends
Procurement & Tenders
GDP: $313.4 billion
Currency: Philippine Peso (PhP)
Language: Pilipino (official; based on Tagalog) and English (official)
The Philippine medical equipment market remains a lucrative one 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 three major hospital developers – 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 6.7% (2017 est.), and hospital expansion and upgrading.
Official Department of Health statistics indicate that there are about 2,000 licensed hospitals in the country, of which about 60% are privately owned. Total bed capacity is more than 100,000. Hospitals base buying decisions on quality, but above all, on price.
Achieving full coverage to quality health is an objective of the current administration. To date, about 92% of Filipinos are now 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 service, 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.
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. He/she registers with the Food & Drug Authority (FDA) before operating and receives a License to Import and a License to Operate (LTO) from this agency FDA.
CS Philippines can connect U.S. companies to Philippine distributors who are licensed and accredited by the Philippine FDA and who have 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 their higher budgets. Middle to upper-classes predominantly use private healthcare services, while lower middle- to lower-classes consult with public health practitioners and go to public hospitals.
Incidence rates for hypertension and heart diseases, lung and kidney diseases, and other respiratory diseases have remained high. Most hospital improvements concentrate on specialized services for radiology, cardiac, lung and kidney examinations, and pathology to address the problem. Demand for ECGs, CT Scans, X-ray machines, Dialysis machines, and other laboratory instruments will continue to grow. Demand for dermatology services and clinical aesthetics procedures are also growing.
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.
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 92% of the population. The goal is 100% coverage.
Current demand reflects healthcare requirements for growing incidences of hypertension, diabetes/kidney diseases, TB/respiratory ailments, and cancer. 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 the majority of 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 2018.
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), was created to oversee the regulation of medical devices/equipment.
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:
A Certificate of Exemption may be obtained in 30 calendar days.
The 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.
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.
Philhealth paid out a total of 361 million pesos (about $6.9 million) in “Z benefit” claims in 2017. According to the DOH, the Z benefit package covers peritoneal dialysis, coronary artery bypass graft surgery, breast cancer surgery, kidney transplantation, and ventricular septal defect surgery.
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 happening in the near future that will affect U.S. firms.
The newly approved DOH AO 2018-0002 will apply to all medical devices (and many 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 submit an application to have their product classified.
Medical devices were considered freely importable and “non-registrable” prior to this AO and did not require Certificate of Product Registration (CPR). Since the new AO will take effect in March 2019, medical device imports are still subject to existing FDA regulations and request the FDA’s Center for Device Regulation, Radiation Health and Research (CDRRHR) to issue a Certificate of Exemption (COE) to facilitate the release of imported medical equipment from Bureau of Customs custody.
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). Industry has been expecting fee increases since fees have not changed since 2001 and it is quite obvious that they need to be updated. However, the initially proposed draft of fees circulated to industry has included some surprising figures. In some cases, the fee increases are over 500% and the discrimination in fee structures between local and foreign manufacturers is of great concern. Industry is currently submitting position papers to the FDA and all are looking to see whether the schedule for implementation will begin in the third quarter of 2018 as initially conveyed.
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 12-15, 2018
Arab Health 2019
January 28 - 31, 2019
Dubai, UAE http://www.arabhealthonline.com/
Florida International Medical Expo (FIME) 2018
June 26-28, 2019
Miami Beach, FL
American Association of Clinical Chemistry
Annual Meeting & Clinical Lab Expo 2019
August 4-8, 2019
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, where they excel in.
1. How can US companies sell their medical devices in the Philippines?
US exporters may work through authorized distributors who have experience in handling importations, customs clearance, FDA registration, or directly with hospitals. The US 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 US 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 remains a major concern 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.
U.S. Commercial Service Contact Information
Name: Dey Robles
Position: Commercial Specialist
Phone: (632) 301-2260
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.
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
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