Importation and manufacture of PPE, respirators and ventilators

2020-06-02T16:15:53+08:00 June 2nd, 2020|Insight, Medical Regulation Updates, News & Events|
OSCAR system

Updated guidance on the importation and manufacture of PPE, respirators and ventilators was issued on 26 May 2020 by the Philippines’ Food and Drug Administration (FDA) in Circular 2020-018 which repeals FDA Advisory Nos. 2020-547 and 2020-449 which legislated for Special Access Routes for the their importation and manufacture to help respond to the COVID-19 outbreak.

The Philippines government now considers that there is adequate supply of these essential medical devices. And as a consequence, the increased supply is leading to concerns over the safety and quality of these medical devices used during the pandemic.

The guidance issued in this Circular No. 2020-018 states updated licensing and registration requirements and customs release procedures for the importation and manufacture of PPE, respirators, and ventilators:

Importation or manufacture of PPE

All establishments which intend to import or manufacture of PPE must first obtain a License to Operate as a medical device importer or manufacturer and then they should apply for a Certificate of Product Notification (CPN) before placing the medical devices on the market.

Importation or manufacture of respirators & ventilators

All establishments which intend to import or manufacture respirators or ventilators must first obtain a License to Operate as a medical device importer or manufacturer and then they should apply for a Certificate of Product Registration (CPR) within 3 months after the lifting of State of Public Health Emergency (Proclamation NO 922 s. 2020).

Special note to those establishments who have started the importation or manufacture of PPE, respirators or ventilators under Advisory Nos. 2020-547 and 2020-449

Authorised establishments who have already started to sell and distribute their medical devices without product notification (CPN) or product registration (CPR) pursuant to Advisory Nos. 2020-547 and 2020-449 must apply for a Certificate of Medical Device Notification (CMDN) or a Certificate of Product Registration (CPR) before the 25th August 2020 (three months of the issuance date of Circular No. 2020-018). Non-compliance with this requirement will result in enforceable actions as necessary.

Customs release procedure for PPE, respirators and ventilators

All establishments who wish to import in order to commercialise PPE, respirators or ventilators need to present the importer’s License to Operate to obtain customs release. Whereas foreign donations of these particular medical device do not require this.

General guidance applying to medical devices used in the COVID-19 pandemic

All medical devices for use in the COVID-19 pandemic must adhere to the following guidance and standards as issued by the Philippines FDA regarding the development, design, clinical trial, testing, validation, risk management, manufacture, sterilization (non-exhaustive list) wherever applicable:

  • Philippine National Standards (PNS)
  • Applicable International Standards (ISO or IEC) in absence of the PNS
  • Technical requirements for registration as legislated for under AO No. 2018-002 Guidelines Governing the Issuance of the Authorization for a Medical Device based on ASEAN Harmonized Technical Requirements.

If you have any queries regarding the importation or manufacture of PPE, respirators or ventilators for COVID-19 or our services for medical device registration and representation in the Philippines, please contact us at contact@andamanmed.com.