FREQUENTLY ASKED QUESTIONS
COVID19 – MEDICAL DEVICE
1. What is a Special Certification for COVID19 Test Kit?
This is an FDA authorization issued to companies that wish to distribute COVID-19 Test Kits (PCR and Serologic) commercially.
2. How to apply for a Special Certification for COVID-19 Test Kit, and what are the requirements to be submitted?
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.
3. I am a local manufacturer and I wish to manufacture COVID19 test kits (PCR and Serologic). How can I acquire an FDA Authorization?
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).
4. What documents are equivalent to certificate of product registration issued by the regulatory agency?
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
5. I have been issued a Special Certification for COVID19 Rapid Test Kit. Am I now allowed to distribute these test kits?
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)
6. Where can I verify if the test kit is FDA approved/issued with Special Certification?
- For test kits issued with Special Certification you may check on this link
- Take note however that the approval is company specific. Each company should have a special certification prior to the importation of the product. To request for the list of the importer/distributors, send an email to [email protected] and [email protected] and indicate the reason for the request.
7. COVID-19 Test Kits are readily available online. Can I purchase online?
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).
8. Are Rapid Test Kits used to diagnose SARS-CoV-2 infection?
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:
9. I plan to conduct a mass testing for my employees prior to their coming back for work. Will I be allowed to import test kits since we have a foreign sister company?
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.
10. What is the validity of the Special Certification for COVID-19 Rapid Test Kit?
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.
11. How can I import face masks?
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).
12. Are cloth face masks regulated by the FDA?
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.
13. How can I apply for a License to Operate for Medical Device establishment?
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.
14. I intend to manufacture PPEs/Ventilators/Respirators.
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.
15. I would like to apply for a Certificate of Product Registration for Clinical Thermometers. What are the requirements and procedures?
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.
16. What is the procedure for the donation of COVID-19 related medical devices:
- 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.
