All comments can be sent at [email protected] Deadline of submission of comments shall be by 08 May 2022.
In the effort to combat the pandemic brought by COVID-19, continuous research and development of new technologies are being undertaken both by the private and government sectors to diagnose and detect SARS-CoV-2 infection including its new variants. These emerging technologies pave the way for the government and the healthcare industry to properly address the pandemic as well as the existing and ensuing problems brought by the deadly disease. The immediate availability of safe emerging new technologies to the general public has become one of the major concerns of both the government and the healthcare sector.
To ensure the quality, safety, accuracy and performance of these emerging new medical device technologies/ in vitro diagnostic medical devices (IVDMDs) on detection and diagnosis of COVID-19 in line with the mandate of the FDA to regulate these products by virtue of Republic Act No. 9711 otherwise known as the Food and Drug Administration (FDA) of 2009, this Circular is hereby issued.
This Circular is issued to provide specific guidelines on the requirements for the Special Certification to be issued for emerging new IVDMDs for SARS-CoV-2 infection.
This issuance shall apply to manufacturers, traders, and distributors (importers, exporters and wholesalers) of new medical technology equipment and devices to be used for the diagnosis/screening, confirmatory and monitoring/surveillance of SARS-CoV-2 infection.
A. All emerging new IVDMD products to be used for the diagnosis/screening, confirmatory and monitoring/surveillance of SARS-CoV-2 infection shall require an FDA Special Certification prior to manufacture, import, export, sale or offer for sale.
B. The following requirements shall be submitted for the issuance of an FDA Special Certification for emerging new IVDMD products for SARS-CoV-2 infection:
- Letter of Intent
- A government issued certificate attesting to the status of the manufacturer with regard to the competence and reliability of the personnel and facilities, a Quality Systems Certificate of approval, or a compliance certificate for ISO 13485. For imported IVD, the copy of the certificate shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct.
- For imported IVD, certificate of product registration, or any equivalent document attesting to the safety, quality and effectiveness of the IVD issued by the National Regulatory Agency or accredited notified body in the country of origin. The copy of the certificate shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct.
- Clinical studies and performance evaluations preferably conducted by National Regulatory Authorities or independent parties [World Health Organization (WHO), Foundation for Innovative Diagnostics (FIND) and accredited laboratories)
- Product profile
- Product labels (primary, secondary packaging and package insert)
V. SEPARABILITY CLAUSE
In the event that any term, part, or provision of this Circular is declared invalid or unenforceable, the validity or enforceability of the remaining terms, portions or provisions hereof shall not be affected, and this Circular shall be construed as if it did not contain the invalid or unenforceable term, part, or provision.
This Circular shall take effect fifteen (15) days following its publication in the Official Gazette or in a newspaper of general circulation and upon filing three (3) certified true copies with the University of the Philippines Law Center – Office of the National Administrative Register