Philippine Medical Devices
The Philippines suffers from high disease prevalence rate for non – communicable diseases (e.g., hypertension, diabetes, lung/chronic respiratory diseases) which account for 32.9%, reproductive health diseases (HIV/AIDS) at 11.2%, nutritional deficiencies (e.g. anemia, vitamin A deficiency, and iodine-deficiency disorders) at 10%, non-disease specific at 7.5%, injuries at 5.1%, and other and unspecified diseases / conditions at 2.8%.
The Philippine medical device is highly dependent on imports. Increasing death rates caused by cardiovascular Imported medical devices account for 99.2% of the market. Local medical device industry is limited to production of spare parts, medical consumables, and spare parts. Main suppliers are from: China, Germany, Singapore, and Japan. The United States accounts for 10% of the market. Key players present in the Philippines include GE Healthcare, Medtronic, Abbott, BD, Boston Scientific, Siemens, and Philips.
diseases, respiratory diseases, hypertension, diabetes, and tuberculosis drive the demand for quality medical devices and medical equipment to treat patients. U.S. export opportunities are in:
• Innovative diagnostic imaging (3D imaging, MRI, CT scan, fluoroscopy, ultrasound, echocardiography)
• Innovative cancer treatment equipment
• Innovative point of care devices
• Dialysis machines
• Cardiac devices
• Respiratory devices
• Dental products
• Orthopedic products
The Philippine signed the Universal Health Care Law (UHC) in 2019. The UHC aims to cover at least 50% of medical expenses to encourage more Filipinos to visit to specialty doctors and undergo advanced medical procedures. As of 2020, there are 1,915 hospitals across the Philippines including 1,148 private hospitals and 767 government hospitals with a total bed capacity of 22,773. The Philippine Department of Health directly control and manage 66 hospitals. There are around 900 hospitals under the National Health Insurance Program – PhilHealth.
Demand for medical devices is driven by large hospital groups such as Metro Pacific Corporation (MPIC), Qualimed Health Network, and Mt. Grace Hospitals, Inc. who continue to acquire current facilities and invest in new hospitals. According to Ken Research, Hospitals contribute 70% of the total medical device revenue while clinics and diagnostic Labs contributed 22.5% combined and 7.5% was attributed to other healthcare institutions (home healthcare, telemedicine centers, and others).
Medical device registration is managed by the Center for Device Regulation, Radiation Health and Research of the Philippine Food and Drug Administration (CDRRHR - FDA). The Philippines is a signatory to the ASEAN Medical Device Directive that classifies medical devices according to four classes A, B, C, and D and ranked from low to high risk. The FDA is plagued with backlogs and bureaucratic processes. Average registration processing time for medical devices is around 180 working days.
The Philippine FDA published FDA Circular No. 2021-002 which provides guidelines for the full implementation of the ASEAN harmonized technical requirements for all medical devices classified under Class B through D to apply for Certification of Medical Device Notification (CMDN) and apply for the Certification of Medical Device Registration (CMDR) at least three months prior to the expiration of CMDN. The Philippine FDA is currently soliciting comments from the industry regarding registration of In-vitro diagnostic (IVDs) products. As it stands, IVDs will be required to apply for a CMDN and a CMDR after two years.
U.S. manufacturers must appoint a licensed importer and distributor. The Philippine company will be responsible for registration and licensing with the Philippine FDA, product market performance, and after-sales services.
Trade Shows:
Medical Philippines Expo 2022
August 24-26, 2022
Location: SMX Convention Center, Pasay City, Philippines
Website: http://www.philmedical.com
Medical Fair Asia
August 31 – September 2, 2022 (Physical) / September 3-9, 2022 (Online)
Location: Marina Bay Sands, Singapore
Website: https://www.medicalfair-asia.com/
Link to FDA Circular No. 2021 – 002: https://www.fda.gov.ph/wp-content/uploads/2021/01/FDA-Circular-No.2021-002.pdf
The U.S. Commercial Service can assist you in identifying opportunities and local partners in the Philippine healthcare sector. Please contact Commercial Specialist Katrina Domingo at katrina.domingo@trade.gov.