The ASEAN Medical Device Directive (AMDD) was previously drafted in the AO 2018-002. In relation to this, PFDA has released the following subsequent updates for its full implementation with the end goal of complete harmonization:

1. 1. Updated list of Registrable Medical devices and their classification- FDA Circular No. 2020-001A

Last January 4, 2021, an amendment to the Annex A of FDA Circular No. 2020-001 was released.   This clarified the ambiguous classification of 31 items of the 137 medical devices listed in the previous version. Two items were added: ventilator and resuscitator. The rest of the medical devices in the FDA Circular No. 2020-001 remain unaffected by this circular.  This will serve as the basis for the classification and type of certificate that needs to be applied for (CMDN or CMDR).

2. 2. Notification of Class B-D Medical Devices – FDA Circular No. 2021-002 and 002-A

 These are the medical devices that are not listed in Annex A of FDA Circular No. 2020-001 or its subsequent amendments but classified under risk class B-D based on AMDD. Upon the implementation of FDA Circular No. 2021-002, such devices will now require a CMDN prior to importation and marketing instead of direct importation using a valid LTO.  Class B-D CMDN applications will follow the same requirements as a Class A CMDN application. The table below summarizes the different certificates for medical devices that can now be applied with PFDA and their important differences:

TYPE OF CERTIFICATE	VALIDITY	REGULATORY BASIS	AFTER EXPIRY	APPLICATION FEE
CMDN class A	5 years	AMDD	Renew CMDN	P 7, 575
CMDN class B-D	2 years	AMDD	Apply for CMDR	P 3, 030
CMDR class B-D	5 years	AMDD, FDA Cir. 2020-001A	Renew CMDR	P 7, 575

By 2023, all class B-D CMDNs must be converted to CMDRs. The timeline for the transition is given in FDA Circular No. 2021-002 A and illustrated in the figure below:

1. 3. Class A reference List- PFDA released FDA Circular No. 2021-017

The responsibility of determining the risk classification and consequently the type of certificate to be applied for together with its requirements still lie on the applicant or the manufacturers, importers, distributors, and other stakeholders. To aid in this process, PFDA has released FDA Circular No. 2021-017. While this might not be considered exhaustive because of the wide range of medical devices being produced worldwide, this is a 29-page list that is grouped according to medical specialization.

With all these regulations, the importance of the correct risk classification and type of authorization to be applied for cannot be overemphasized.  For more information and for your guidance, you can contact our Business Team for a consultation and strategy discussion on how you can register your medical device products in the Philippines.

Other Important PFDA Announcements

1. 1. Updated COVID-19 Test Kit Registration Procedure

Last year, PFDA has issued special certification for the different types of COVID-19 test kits: RT-PCR, antigen, and antibody, to meet the needs brought about by the pandemic. As the supply of the different test kits becomes stable, and with the availability of benchmark data from other international organizations, PFDA has updated its procedure and requirements. In addition to the technical documents and approval from the country of origin, PFDA is now requiring applicants to pass the actual technical evaluation conducted by the Research Institute for Tropical Medicine (RITM) using the sensitivity and specificity criteria set by the World Health Organization (WHO).  You can check out our previous article for more details.

1. 2. Launching of the Online Disclosure Report System (ODRS) in compliance with DOH AO No. 2021-036

Through FDA Advisory No.2021-2035, PFDA reminded the public regarding the submission of the First Disclosure Report on their Financial Relationships with Health Care Providers and Health Care Professionals for the first half of the year using the newly launched ODRS.

The following items must be reported:

- All sponsorship of events, research and educational grants, payment of services, space rentals or facility fees, donations for patients, and other service arrangements;

- All donations, educational grants, research funding, sponsorship related to events, travel, and accommodation, registration fees, honoraria, support for continuing professional development, royalties, current or prospective ownership or investment interest, consultancy/speakership fees, among other arrangements, and

- For drugstores, payments for disease awareness partnership programs, training of drugstore pharmacists conducted by companies or training of drugstore pharmacists conducted by third parties on behalf of companies, or financial relationships of a similar nature

The reports are due on September 15, 2021, while the schedule for the succeeding reports will be as follows:

Covered period                                    Deadline for updating in the ODRS

First half of the current year*   15 July of the current year

Second half of the current year          15 January of the succeeding year

 

 

References:

1. FDA Circular No. 2020-001A
2. FDA Circular No. 2021-002
3. FDA Circular No. 2021-002A
4. FDA Circular No. 2021-017
5. Qualtech News May 22 Article
6. FDA Advisory No. 2021-035
7. Lexology Article on AO 2021-036