• 2020-08-11 05:46:22

PFDA adjusted some transactions that usually requires face to face interactions. However, PFDA reminded that post-marketing surveillance activities for all medical devices will be continue.

• 2020-06-16 08:03:29

PFDA released updated guidelines for the importers and manufacturers of PPEs, ventilators, and respirators in relation to the COVID-19 situation.

• 2020-06-16 08:03:29

PFDA publishes new guidelines regarding License to Operate (LTO)-related transactions for establishments.

• 2020-06-11 10:06:42

PFDA issues FDA Circular No. 2020-016 to remind public that online sale of approved COVID-19 test kits is prohibited. Furthermore, the kits are for medical professional use only. PFDA urges law enforcement as well as the public to be vigilant regarding COVID-19 test kits in the market.

• 2020-05-12 08:23:22

PFDA reminds the public to buy health products, including medical devices and supplies, only from online sellers with proper authorization/s. In a separate announcement, PFDA released a guidance for manufacturers of PPEs, ventilators and respirators during the COVID-19 pandemic.

• 2020-04-14 05:08:33

PFDA implemented FDA Circular No. 2020-001 last March 13, 2020. However, PH government enforced enhanced community quarantine due to COVID-19 pandemic last March 17, prompting PFDA to release several issuances regarding guidelines on PFDA transactions during the quarantine period.

• 2020-02-21 07:26:10

PFDA released FDA Circular No. 2020-001 as initial implementation of Administrative Order No. 2018-0002 (Guidelines Governing the issuance of an authorization for a medical device based on ASEAN Harmonized Technical Requirements).

• 2020-02-21 07:07:52

The PFDA released the draft fees in preparation to the authority’s adaptation to the ASEAN Medical Device Directive (AMDD) risk-based classification.

• 2020-05-06 09:31:48

PFDA starts to iron out flaws ahead of the upcoming implementation of AO 2018-0002. Things to keep an eye out for are the new guidelines for risk classification, separate scope for refurbished medical devices, guidelines and process of securing licenses for local medical products.

• 2020-05-06 05:18:20

The draft guidance on labeling is catered to provide a comprehensive information on medical device and IVD use among patients and/or end-users. The Guidance is expected to take effect after 15 days following its official publication.