FREQUENTLY ASKED QUESTIONS
COVID19 – MEDICAL DEVICE
This is an FDA authorization issued to companies that wish to distribute COVID-19 Test Kits (PCR and Serologic) commercially.
FDA Memorandum No. 2020-006: Issuance of Special Certification for Imported Test Kits of COVID 19 issued on March 12, 2020 states the following requirements:
- Letter of Intent
- Valid License to Operate as Medical Device Distributor/Importer/Exporter
- Fee of Php500.00 plus LRF (Php10.00)
- Product registration issued by the regulatory agency or their accredited third party from the countries with established regulation such as but not limited to US Food and Drug Administration, Therapeutic Goods Authority, European Union, Health Science Authority, Pharmaceutical and Medical Device Authority, Ministry of Food and Drug Safety (Korea) and Health Canada: or WHO prequalification or EUL
FDA Circular No. 2020-006 entitled “Guidance for Applications and Transactions at the Food and Drug Administration in light of the Community Quarantine Declaration” together with its amendment issuance FDA Circular No. 2020-006-A state the procedure on how to apply for the said certificate.
For companies who intend to manufacture COVID19 Test Kits, a Medical Device License to Operate (LTO) as Manufacturer must be secured first. FDA Administrative Order 2016-0003 entitled Guidelines on the Unified Licensing Requirements and Procedure of the Food and Drug Administration (FDA) provides the guidelines and processes for application. The site master plan that need to be prepared by the company in preparation for the inspection can be downloaded at the FDA website under CDRRHR Downloadables.
After the issuance of the LTO, the Special Certification for COVID19 Test Kit must be secured (FDA Memorandum No. 2020-006: Issuance of Special Certification for Imported Test Kits of COVID 19). The manufacturing company of COVID19 Test Kits must submit the product to validation testing conducted by the Research Institute for Tropical Medicine (RITM).
The following documents are equivalent to a certificate of product registration but are not limited to:
- Certificate of Emergency Use approval from Korea Centers for Disease Control and Prevention or Ministry of Food and Drug Safety from Korea
- Provisional Authorization from Health Sciences Authority (HSA) of Singapore
- Nucleic Acid Reagent Test Kits for the Novel Corona (2019-nCoV) approved by the National Medical Products Administration (NMPA) of China
- Emergency Use approval from US Food and Drug Administration
- Therapeutic Good Administration (TGA) Letter of Inclusion from Australia
- CE approval issued or duly recognized by the national regulatory agency or certification issued by a Notified Body for European Countries
Yes, however, a performance validation conducted by the Research Institute for Tropical Medicine (RITM) must be complied within a specified period as part of the FDA’s post-marketing surveillance of health products. You may check the FDA Memorandum No. 2020-011(Performance Testing of Antibody Test kits with Issued Special Certification)
- For test kits issued with Special Certification you may check on this link
The FDA has issued FDA Circular No. 2020-016 prohibiting the online selling of COVID19 test Kits to protect the public against the use and purchase of uncertified COVID19 test kits. This is to ensure the safety, efficacy and quality of In Vitro Diagnostic medical devices in the country. Further, this is not a Do-It-Yourself testing, it must be done by a licensed physician or a trained health professional. Please refer to these FDA Issuances: FDA Advisory No. 2020-497 (Distribution of FDA approved COVID-19 Rapid Antibody Test Kits), FDA Advisory No. 2020-498 (Purchase and Administration of FDA approved COVID-19 rapid antibody test kits) and FDA Circular No. 2020-004 (Prohibition of Selling of COVID-19 Testing Kit without Authorization from FDA).
Rapid test kits detect the presence of antibodies in an individual’s blood serum. It is important to consider the timing of the infection and the condition of the patient during the time of specimen collection. The selection of the type of kit to be used is also dependent on the indication, the information the doctor wants to obtain, and the specification of the kit. Interpretation must be done with caution and clinical correlation. You may read the full advisory: FDA Advisory No. 2020-671 (Varying Specifications and Use of COVID-19 Rapid Antibody Test Kits). Additionally, you may click this link:
The FDA has already approved a number of COVID-19 test kits for local marketing. Thus, all companies who would require mass testing for their employees can purchase the COVID-19 test kits from these importers. A list of the local importers of the COVID-19 test kits with issued Special Certification is available upon request.
Administration of the test must be performed by a doctor or a trained health professional as indicated in FDA Advisory No. 2020-497 and FDA Advisory No. 2020-498.
The Special Certification for COVID-19 PCR Test Kit has no validity and will remain valid during this emergency situation, unless revoked. However, for the Special Certification for COVID-19 Rapid Test Kit, a performance validation conducted by the Research Institute for Tropical Medicine (RITM) must be submitted within a specified period as indicated in the FDA Memorandum No. 2020-011.
A License to Operate as a Distributor/ Importer must be obtained by the company prior to importation. After securing the required LTO, importers are advised to apply for a Certificate of Product Notification (CPN) prior to commercial sale and distribution (FDA Circular 2020-018: Interim Guidelines of the Importation and Manufacture of Personal Protective Equipment (PPE), Ventilators and Respirators to be used in the COVID-19 Pandemic). Face masks that are for commercial use may be imported and released from the Bureau of Customs (BOC) by presenting a copy of the importer’s valid License to Operate (LTO).
Cloth face masks are not under the jurisdiction of the FDA, thus, no authorization/certification will be issued by this Agency as of the time being. However, if the cloth facemasks will be used in medical institutions/facilities then the products are be now considered as medical devices and should comply with the FDA regulation for facemasks.
For importers of Personal Protective Equipment (PPE) and specific medical devices essential for the management of COVID-19 for commercial distribution, the Anti-Red Tape Authority (ARTA) and the Food and Drug Administration (FDA) signed a Joint Memorandum for the Creation of Bayanihan One Stop Shop (BOSS) for securing a License to Operate to import COVID-19 critical commodities for commercial distribution (Joint Memorandum Circular No. 01 Series of 2020).
Take note however that for the importation of COVID-19 Test Kits, the regular LTO should be secured. Application for this is guided by FDA Circular No. 2016-004 for the procedure on the use of the new application form for LTO thru FDA electronic portal, and Administrative Order No. 2016-0003 for the guidelines on the Unified Licensing Requirements and Procedures.
All establishments that intend to manufacture PPEs/ventilators/respirators are required to secure an LTO as Medical Device Manufacturer. Please see Administrative Order No. 2016-0003 for the guidelines on securing a License to Operate.
Please be guided by FDA Circular No. 2020-018 regarding the application for the product notification/registration.
Clinical Thermometer is a class B medical device and included in the list of registrable products based on FDA Circular 2020-001. Thermometers are therefore required to be registered. Administrative Order No 2018-002 and FDA Circular No. 2020-001 indicates the requirements for CMDR.
The application for CMDR must be submitted through [email protected] Only paid applications will be processed. This is few of the COVID related products that are allowed to apply for initial application.
- COVID-19 Test Kit Donations – certification for donated COVID-19 test kits shall be coursed through solely by the Bureau of International Health Cooperation (BIHC) of the Department of Health (DOH).
- PPEs – for foreign donations of PPEs, clearance from FDA shall not be needed.