After a public symposium last February 28, PFDA announced the full effect of FDA Circular No. 2020-001 by March 13, 2020. In this implementation, PFDA started accepting applications for Certificate of Medical Device Registration (CMDR), Certificate of Medical Device Notification (CMDN) and Certificate of Medical Device Listing (CMDL). This implementation was affected by the March 17, 2020 announcement by the Philippine government enforcing an enhanced community quarantine (ECQ) for the whole of Luzon in response to the COVID-19 pandemic. PFDA is one of the government offices affected by ECQ. PFDA released several guidelines with respect to PFDA transactions during ECQ.
Additional Details from the February 28 Symposium regarding FDA Circular 2020-001
Initial registration
a. PFDA will not have a risk classification service to verify medical device’s risk class prior to registration or notification.
b. For those under class A, even those not included in FDA Memorandum Circular No. 2014-005 and 005-A should be applied for a CMDN. The submission is through the online portal of FDA. The documents will go through a pre-assessment stage which can be repeated as needed before payment of the application fee. Once it passes the evaluation stage, certificate will be released online. Applicant can print certificate by themselves after approval. If the application fails the evaluation, then proceed to reapplication.
c. CMDR applications for devices with risk class B-D that are included in FDA Memorandum Circular No. 2014-005 and 005-A must be submitted manually to FDA.
d. Class B-D that are not included in the 2014-005 and 005-A and 2020-001 are considered non-registrable and can be imported directly. PFDA will communicate to Bureau of Customs. This will be uploaded soon in PFDA website.
Medical devices with existing certificates
a. By Nov 3, 2021, PFDA expects all existing and applicable COEs are converted to CMDN.
b. CPR (Class A) will be converted to CMDN after renewal. CMDN will have a new registration number. For labels that bear the old CPR no., PFDA will allow to importer/distributor to exhaust all remaining stocks. This must be communicated clearly via letter.
c. Class B-D Devices that already have valid CPR will not be affected. CPR will not be converted to CMDR upon renewal. It will continue to be CPR.
FDA Circular No. 2020-006 and 006A “Guidance for applications and transactions at the Food and Drug Administration in the Light of the Community Quarantine Declaration”
PFDA limited the types of transactions that can be made to their office as they adopt a work from home arrangement beginning April 2. Communications and submissions can be done through e-mail following prescribed content, file size and format.
The transactions accepted by PFDA Medical Device division are as follows:
(1) initial registration of COVID-19 related devices and IVDs,
(2) compliance,
(3) CMDN applications,
(4) sales promo permit,
(5) Compassionate Special Permit, CSP
(6) notification of sources.
Here are additional guidelines announced:
- Initial registration for other medical devices and in-vitro diagnostic devices and applications for CPR variation are suspended until further notice.
- Notarization of documents is waived but must be submitted upon lifting of ECQ.
- CPRs due for renewal on 01 March 2020 to 30 June 2020 shall be given an automatic validity extension of four months after the expiration date of the CPR. Within the extension period, renewal application must be submitted.
- Notices of Deficiency (NODs) with compliance period ending on 23 March 2020 onwards shall be extended for one month but may be submitted electronically.
- For approved certificates, the release is temporarily through a scanned copy which will be sent to the provided e-mail address of the applicant.
Importation of COVID-19 Critical Commodities for Commercial Distribution
FDA together with the Bureau of Customs (BOC) and the Anti-Red Tape Authority, released Joint Circular No. 01 series of 2020 and created the Bayanihan One Stop Shop (BOSS) to expedite importation of critical supplies in the fight against COVID19. License to Operate (LTO) and application for importation can now be filed electronically through the links https://boss.fda.gov.ph/applications and https://client.customs.gov.ph/index.php, respectively.
The applicant must submit the documents and wait for the evaluation through a confirmation e-mail. Other concerned agencies are coordinated through Viber messages in case there is a need to verify importer’s business registration. An order of payment will be received by the applicant and may utilize BancNet Online or LandBank On-Call Payment Facility. Electronic LTO will be issued once payment is posted. Likewise, clearance and release of shipment will be done by BOC after confirmation of payment.
The items covered by this regulation are as follows:
- Personal protective equipment- gloves, gowns, coveralls, body suits, face masks, goggles, face shields, shoe cover, head cap/cover, boots
- Medical devices- all types of adhesive,(adhesive tape, adhesive bandage), preformed anchor, bandage, base paste, reusable cannula, cap (disinfection, seal, taper, dead end),clinical thermometer analog type (except mercurial type),cotton (medical/hospital use), dressing, flowmeter (all types, gauze, examining non-sterile gloves, lubricating gel/jelly (external, internal) gloves, luer lock, nasal spray (without claims), nasopharyngeal airway, stop cock, surgical drape, sterile, syringe without needle, surgical/medical tape
FDA also released FDA Circular No. 009 and 009A, Guidelines on the Identification, Notification, Evaluation, Regulatory Enforcement Action, and Review and Monitoring of Donated Health Products Solely Intended to Address COVID-19 Public Health Emergency. This applies to face masks including n-95 masks, shoe covers, gloves, head covers, gowns, goggles/ face shields, covid-19 diagnostic test kits, alcohol, hand sanitizers, etc., ventilators, respirators and their respective accessories, and other health products that may hereinafter be identified and listed by the FDA. The list of COVID-19 test kits is updated regularly. As of writing there are 9 items listed under rapid test kits and 21 under PCR-based kits. Almost all the test kits are imported except for one locally made PCR-based kit.
References:
1. PFDA Circular No. 2020-006A
3. Joint Memorandum Circular No.01 Series of 2020
4. List of COVID Registered Kits