Romeo C. Ongpoy, Jr., COVID-19 & the medical device regulations in the philippines, ASIO Journal of Medical & Health Sciences Research (ASIO-JMHSR), 2025, 8(1): 1-8.
Romeo C. Ongpoy, Jr.
Philippine Science High School, MIMAROPA Region Campus
The objective of this study is to consolidate existing documents from the Philippine regulatory bodies controlling the Medical device regulations and draw observation on emphases, innovation and response of the Philippine government in relation to medical device regulations during the early stage of COVID-19 pandemic. To do this, an exhaustive collection of related memorandums, announcements, press release, press statements, circulars, draft and advisories from January to August 2020 were gathered, tabulated, summarized and arranged chronologically from all the government agencies in the Philippines responsible for the control of medical devices. About this study, it can be observed that the regulations of the Philippine government as to medical devices are focused on 3 things: (1) Control of the prices of Protective Personal Equipments (PPEs); (2) Relaxing the regulations for import of medical devices to facilitate availability; and (3) Control on the proliferation of unregistered, uncertified, unnotified and misbranded medical devices used against COVID-19.It can be concluded thatthere is mostly proactive effort from the Philippine government in providing quality and adequately priced medical devices to Filipinos based on the documentary releases of its regulatory agencies.
Key words: Medical device; Philippines; COVID-19; Medical device regulations; Regulatory affairs.
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DOH (2020, February 5). Reiteration of the Price Freeze of Essential Emergency Medicines due to the 2019 nCoV Health Event [Memorandum]. Department of Health-Philippines.
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FDA (2020, April 1). Distribution of FDA Approved COVID-19 Rapid Antibody Test Kits [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 April 2). Purchase and Administration of FDA Approved COVID-19 Rapid Antibody Test Kits [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 April 2). Amendment to FDA Circular No. 2020-006 Entitled “Guidance for Applications and Transactions at the Food & Drug Administration in the Light of the Community Quarantine Declaration” Issued on 17 March 2020 [Circular]. Food & Drug Administration-Philippines.
FDA (2020 April 3). FDA Approves the First Locally Manufactured Test Kit for COVID-19 for Commercial Use [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 April 6). Updated Procedure for FDA Clearance of Personal Protective Equipment (PPE) Prior to Customs Release [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 April 8). Interim Guidelines on the Manufacture of Personal Protective Equipment (PPE), Ventilators, and Respirators in Light of COVID-19 Situation [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 April 8). FDA Warns the Public on Drugs & Vaccines with Unproven Claims for COVID-19 Treatment [Press Statement]. Food & Drug Administration-Philippines.
FDA (2020 April 14). Amendment to Department Memorandum No. 2020-0144 Dated March 30, 2020 Entitled “Updated List for the Price Freeze of Essential Emergency Medicines and Medical Devices Due to the Coronavirus Disease 2019 (COVID 19) Health Event [Memorandum]. Food & Drug Administration-Philippines.
FDA (2020 April 15). Reiteration of the Amendment of the Updated List for the Price Freeze of Essential Emergency Medicines and Medical Devices Due to the Coronavirus Disease 2019 (COVID 19) Health Event [Memorandum]. Food & Drug Administration-Philippines.
FDA (2020 April 16). Additional Payment Channel [Memorandum]. Food & Drug Administration-Philippines.
FDA (2020 April 16). Varying Specifications and Use of COVID-19 Rapid Antibody Test Kits [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 April 20). RITM to Evaluate FDA Approved COVID-19 Rapid Antibody Test Kits [Press Statement]. Food & Drug Administration-Philippines.
FDA (2020 April 20). Performance Testing of Antibody Test Kits with Issued Special Certification [Memorandum]. Food & Drug Administration-Philippines.
FDA (2020 April 22). Advisory for the Issuance of Special Permit for Medical Radiation Facilities using Loaned Mobile X-Ray Devices during the COVID-19 Pandemic [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 April 22). PH Solidarity Trial for COVID-19 Treatments Receives Green Light from Ethics Review Body [News Release]. World Health Organization
FDA (2020 April 24). Releasing of FDA Authorization and Payment thru Fund Transfer [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 April 29). FDA Clearance of Respiratory Therapy Devices Prior to Customs Release [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 April 29). Amendment to Include Respiratory Therapy Devices in the List of Medical Devices Covered by FDA Circular No. 2020-009, as Amended by FDA Circular No. 2020-009-A [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 April 30). Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Lerkonn Infrared Thermometer” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 May 5). Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Infrared Thermometer” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 May 5). Public Health Warning Against the Sale and Purchase of the Uncertified COVID-19 Test Kit “Bioeasy 2019-nCoV IgG/IgM GICA Rapid Test” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 May 6). Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Devices: (1) Pharmaline Monitor Digital Thermometer (2) MIcrolife Digital Jumbo LCD Thermometer [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 May 7). Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Cawono D380 Non-Contact IR Thermometer” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 May 7). Public Health Warning Against the Unapproved and Misleading Health Claims of Medical Devices that Decrease the Risk for COVID-19 Infection [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 May 15). Prohibition on the Selling of Essential Emergency Medicines and Medical Devices Beyond the Price Ceiling/Range set by the Department Memorandum No. 2020-0058 [Circular]. Food & Drug Administration-Philippines.
FDA (2020 May 26). Interim Guidelines of the Importation and Manufacture of Personal Protective Equipment (PPE), Ventilators and Respirators to be Used in the COVID-19 Pandemic [Circular]. Food & Drug Administration-Philippines.
FDA (2020 May 27). Public Health Warning Against the Purchase and Use of Unregistered Product “Richskin Case Germs Away with Vitamin E Ethyl Alcohol 70% Solution” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 May 28). Public Health Warning Against the Sale and Purchase of the Uncertified COVID-19 Test Kit “Femometer COVID-19 IgG/IgM Rapid Test Cassette” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 May 29). Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Topcare Digital Infrared Ear Thermometer” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 May 30). Reissuance of the Guidelines on the Identification, Notification, Evaluation, Regulatory Enforcement Acton, and Review and Monitoring of Donated Health Products Solely Intended to Address COVID-19 Public Health Emergency [Circular]. Food & Drug Administration-Philippines.
FDA (2020 June 3). Updated Customer Mobile Hotlines of FDAC [Announcement]. Food & Drug Administration-Philippines.
FDA (2020 June 4). Public Health Warning Against the Purchase and Use the Uncertified COVID-19 Test Kit “DeepBlue COVID-19 (SARS-COV-2) Antibody Test Kit)” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 June 4). Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Miniland Thermosense Forehead and Ear Contact Thermometer” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 June 10). System Maintenance [Announcement]. Food & Drug Administration-Philippines.
FDA (2020 June 10). Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “Testsealabs One Step Rapid Test-SARS-COV-2 IgG/IgM Test Cassette” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 June 10). On the Use of Radiation Devices in the Diagnosis of COVID-19 Infections [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 June 10). Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Infrared Thermometer” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 June 15). Public Health Warning Against the Purchase and Use of the Uncertified COVID-19 Test Kit “WIZ BIOTECH Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2”. Food & Drug Administration-Philippines.
FDA (2020 June 15). Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Non-Contact IR Thermometer” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 June 15). Public Health Warning Against the Purchase and Use of Unregistered Medical Device “Non-Contact IR Thermometer” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 June 19). List of FDA Notified Medical Face Masks [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 June 23). Public Health Warning Against the Purchase and Use of Unregistered Medical Device Product “Thermometer in Foreign Characters” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 June 29). Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Device Products: (1) Yuwell Clinical Digital Thermometer (YT308) (2) Yuwell Clinical Thermometer [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 July 1). List of Notified Hand Sanitizers by FDA [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 July 2). New Normal Operational Guidelines of the Food & Drug Administration (FDA) at the Food & Drug Action Center (FDAC) [Circular]. Food & Drug Administration-Philippines.
FDA (2020 July 9). Public Health Warning Against the Purchase and Use of the Following Unregistered Medical Device Products: (1) Forehead Thermometer TG8818A in Foreign Characters (2) Forehead Thermometer in Foreign Characters [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 July 15). Public Health Warning Against the Purchase and Use of Unregistered Medical Device Product “UNI-T UT300R Non-Contact Infrared Thermometer Thermal” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 July 15). Public Health Warning Against the Purchase and Use of Unregistered Medical Device Product “Mokarway HT801 Thermometer Thermal Scanner Non-Contact Forehead [Advisory]. Food & Drug Administration-Philippines.
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FDA (2020 July 20). Public Health Warning Against the Purchase and Use of Unregistered Medical Device Product “Electronic Thermometer TD138” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 July 21). Advise on the Use of Face Mask with Valve [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 July 21). Rescission of FDA Circular No. 2020-011 entitled “Guidelines of Alcohol Based Sanitizer Formulations in Light of the Declaration of State of Calamity due to COVID-19” [Circular]. Food & Drug Administration-Philippines.
FDA (2020 July 22). Payment Through Fund Transfer [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 July 24). Prescribed Quantity of Products for Evaluation [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 July 24). Caution on the Purchase and Use of Unregistered Vaccines for COVID-19 [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 July 27). Public Health Warning Against the Purchase and Use of the Following Misbranded Face Masks in Foreign Characters: (1) Fu Le Bang Disposable Mask (2) Flag World Face Mask (3) Mask [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 July 30). Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “Leelvis Non-contact Electronic Thermometer” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 August 12). Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “Nitrile Disposable Gloves Powder-Free, Non-Sterile” [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 August 17). List of Other Approved COVID-19 Test Kits for Commercial Use [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 August 20). Updated Guidelines for Application of Authorizations at the Food & Drug Administration in Light of the Community Quarantine Declarations [Circular]. Food & Drug Administration-Philippines.
FDA (2020 August 20). No Face to Face Interaction at the Food and Drug Action Center (FDAC) on 24 August 2020, Monday, Until Further Notice [Announcement]. Food & Drug Administration-Philippines.
FDA (2020 August 24). Food and Drug Action Center (FDAC) New Normal Operational Guidelines of the Food and Drug Administration [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 August 24). Regulation of Face Shield [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 August 25). Conduct of Risk-Based Local Inspections in the Light of the COVID-19 Pandemic [Circular]. Food & Drug Administration-Philippines.
FDA (2020 August 25). Reiteration of DOH Administrative Order No. 2012-0007 as Amended [Advisory]. Food & Drug Administration-Philippines.
FDA (2020 August 26). Further Amendment to FDA Circular (FC) No. 2020-007 entitled “Guidelines in the Implementation of the Use of Electronic Means of Prescription for Drugs for the Benefit of Individuals Vulnerable to COVID-19 [Circular]. Food & Drug Administration-Philippines.
FDA (2020 August 28). List of Approved Rapid Antibody Test Kits for Commercial Use [Announcement]. Food & Drug Administration-Philippines.
FDA (2020 August 28). List of Approved PCR Based Test Kits for Commercial Use [Announcement]. Food & Drug Administration-Philippines.
FDA (2020 August 28). List Approved Immunoassay Test Kits for Commercial Use [Announcement]. Food & Drug Administration-Philippines.