PHILIPPINES: PFDA simplifies LTO-related transactions – July 2020
- 2020-06-16 08:03:29
PFDA publishes new guidelines regarding License to Operate (LTO)-related transactions for establishments.
MorePFDA publishes new guidelines regarding License to Operate (LTO)-related transactions for establishments.
MorePFDA 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.
MorePFDA 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.
MorePFDA 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.
MorePFDA 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).
MoreThe PFDA released the draft fees in preparation to the authority’s adaptation to the ASEAN Medical Device Directive (AMDD) risk-based classification.
MorePFDA 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.
MoreThe Medical Device Market of the Philippines offers Foreign Manufacturers a wealth of opportunities, due to the strong demand for innovative devices and the market’s extreme dependency on foreign imports. With local production covering less than 10% of the national demand and being restricted to a small variety of products, the Philippines promise favorable conditions for foreign companies interested in expanding to Asia.
MoreThe draft guidance on labeling is catered to provide a comprehensive information on medical device and IVD use among patients and/or end-users.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.
MoreThe PFDA Chief has recently reported that the agency has already reduced around 3,500 backlogs out of 80,000 pending applications, including those that were carried over from previous administrations. It was also estimated that this number will be further reduced by 1,400 following the verification and posting of these applications.
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