• 2023-04-24 09:37:45

On March 31, 2023, PFDA has once again extended the application period for one more year for medical device products that were previously considered non-registrable, which currently fall under AMDD risk class B-D. PFDA cites the risk of disrupting the supply chain that may negatively impact the quality of the healthcare system in the country.

• 2023-03-27 08:52:43

PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.

• 2022-11-29 01:55:34

PFDA issued FDA Circular No. 2022-008 that provides a guideline on the abridged process for registration of medical devices among ASEAN member countries.

• 2022-11-29 01:39:35

The Food and Drug Administration (FDA) announced the effectivity extension of FDA Circular No. 2021-025, a guideline for application of authorization due to extended state of public health emergency.

• 2022-10-25 03:59:10

PFDA announced that alcohol swab product registrations will be transferred to the Center for Drug Regulation Research (CDRR). In the same month, PFDA also published a circular that aims to provide guidelines on the use of the FDA eServices Portal System for LTO applications of retailers of Medical Devices.

• 2022-09-27 07:47:09

PFDA held a public hearing about updated draft for the In-vitro diagnostic (IVD) medical device regulation and registration in the Philippines including discussion on transition period and implementation timeline.

• 2022-08-30 03:43:54

PFDA issues the updated regulation for Medical Radiation Devices that aims to provide guidelines for the importation of radiation devices used for both medical and non-medical applications in accordance to AO 2018-0002.

• 2022-07-26 11:24:21

PFDA issued FDA Circular No. 2022-003 that bans the production and all kinds of market exchanges, such as distribution, sale, and advertisement, for several mercury-added devices and related products for safety reasons.

• 2022-07-26 11:22:27

PFDA released a draft circular that provides the requirements for good storage and distribution practices for medical devices, to serve as guidelines for medical device establishments in the Philippines.

• 2022-05-26 13:57:18

PFDA extended the CMDN Requirement of Class B-D Non-Registrable products until March 2023. This will allow continue selling of the affected products in the country using a License to Operate as the requirement. In addition, PFDA shared draft regulations pertaining to the earlier released Abridged Route Evaluation and COVID-19 products using new technologies.