I. BACKGROUND AND RATIONALE
On 26 January 2018, DOH Administrative Order (AO) No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” was issued requiring for the notification of all medical devices under class A (low risk medical device) and registration for Class B (low-moderate risk), Class C (moderate-high risk) and Class D (high risk) medical devices.
Subsections V(1) and V(2) of AO No. 2018-0002 stipulate that a guidance document containing the list of medical devices per classification shall be issued by the Food and Drug Administration (FDA) – Center for Device Regulation, Radiation Health, and Research (CDRRHR). Initial list of medical devices with risk classification was issued through FDA Circular No. 2020-001 entitled “Initial Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements” as amended by FDA Circular No. 2020-001-A re: Amendment to Annex A of FDA Circular No. 2020-001.
Due to the wide array of available medical devices in the market, identifying the risk classification of these health products could be an arduous task for the industry particularly those establishments that are just starting with the medical device business.
To guide the medical device industry on identifying the medical devices that are classified as low risk and in line with the implementation of the above-mentioned provisions of AO No. 2018-0002, this Circular providing the list of Class A medical devices is hereby issued.
This issuance aims to guide the manufacturers, importers, distributors and all other concerned stakeholders regarding the list of medical devices classified as Class A and to help the industry to determine the appropriate authorization specifically Certificate of Medical Device Notification (CMDN) to secure for their medical device products that fall under Class A classification.
- All medical device manufacturers, importers, exporters, and distributors shall apply for a CMDN prior to manufacture, distribution, importation, exportation, sale, offer for sale, and where applicable, promotion, advertising of Class A medical devices listed in Annex A.
- As provided for in AO 2018-0002, if the product is not included in the list, the company shall classify the device based on the intended use and on the classification rules of the ASEAN Medical Device Directive (AMDD). The CDRRHR shall verify the classification made by the applicant and shall reclassify the device if another classification is deemed to be more appropriate.
- The classification of medical devices listed in Annex A is subject to change if there will be additional indicated use, claim and duration of use of the product. New classification of the medical device shall follow the classification rules of the AMDD.
IV. PENALTY CLAUSE
Any establishment found to be in violation of the provisions of this issuance shall be subjected to sanctions and penalties as prescribed under Republic Act No. 9711, otherwise known as the “Food and Drug Administration (FDA) Act of 2009” and its Implementing Rules and Regulations.
V. REPEALING CLAUSE
Provisions of FDA Circular No. 2020-001-A that are inconsistent with this issuance are hereby modified, withdrawn, repealed, and/or revoked accordingly. Furthermore, FDA Memo No. 2018-011 entitled “Regulation of Toothbrush, Sanitary Napkins and Baby Diapers” is amended to reclassify electric toothbrush as a consumer product until further notice or until agreed upon by the ASEAN Medical Device Committee to classify the said product as a medical device.
VI. SEPARABILITY CLAUSE
If any provision in this Circular, or application of such provision to any circumstances, is held invalid, the remainder of the provisions of this Circular shall not be affected.
This Circular shall take effect fifteen (15) days following its publication in a newspaper of general circulation and upon filing three (3) certified copies to the University of the Philippines Law Center.