• 2025-12-26 04:07:51

Qualtech 2025 Southeast Asia Medical Device Compliance Update Webinar Part 2 provides an overview of key regulatory updates in Singapore, Malaysia & the Philippines. The session highlights changes in ASEAN medical device regulations, including system upgrades, regulatory reliance initiatives, evolving submission and classification requirements by Singapore HSA, Malaysia MDA & Philippines FDA, offering insights for medical device compliance planning in 2026.

• 2025-11-10 07:33:05

Join Qualtech's upcoming webinar, "Southeast Asia Medical Device Compliance Update Series 2025 Part 2: Singapore, Malaysia & the Philippines", to gain valuable insights into three of ASEAN's most active and evolving medical device markets. This session will feature Qualtech's local regulatory experts, who will share the latest updates, policy trends, and compliance strategies across Singapore, Malaysia & the Philippines. Updates include current regulatory developments, harmonization efforts, and practical approaches to maintaining compliance while expanding in Southeast Asia.

• 2025-10-27 01:46:53

The 2025 update of the FDA-CDRRHR Citizen's Charter introduces notable changes from its 2024 version, reflecting the agency's continued refinement of service standards, including adjustments in processing timelines.

• 2025-03-26 06:09:21

While the Philippines' ambitious Universal Health Care Act and substantial government investment are creating a rapidly expanding market for medical devices, the nation's overwhelming reliance on imports starkly contrasts with its limited domestic manufacturing capabilities. This situation, however, creates an opening for overseas manufacturers to provide the needed medical devices and take advantage of the increasing market.

• 2025-01-22 06:13:50

Administrative Order No. 2024-0016 sets a new schedule of fees and charges by the Food and Drug Administration (FDA) of the Philippines for all regulated products, including medical devices, drugs, food, and cosmetics. The updated fees aim to simplify compliance for manufacturers and distributors while keeping pace with the growing demands of the healthcare industry. This change ensures more efficient processes for licensing, product registration, and market access.

• 2024-05-07 09:12:46

The Food and Drug Administration (FDA) has recently issued Circular No. 2024-003, which extends the regulatory flexibility and application of CMDN for medical devices under Class B, C, and D that are not listed as registrable medical devices in FDA Circular No. 2020-001-A.

• 2024-04-03 09:16:23

The Philippine Food and Drug Administration (PFDA) released an advisory on March 06, 2024 announcing that COVID-19 Medicines and Devices will no longer be VAT-exempt, effective 01 January 2024. This is due to the expiration of the VAT exemption provision in the CREATE Act.

• 2023-09-27 06:13:09

The Philippine Food and Drug Administration (PFDA) released the 2023 edition of the citizen charter, including updates related to the Center for Device, Radiation Health, and Research (CDRRHR).

• 2023-09-27 05:49:24

The FDA has introduced the Customer Relation Management Information System (CRMIS), a digital platform that enables stakeholders and the public to submit inquiries and follow-ups. The system began on August 28, 2023, and will run until November 30, 2023, as part of the FDA's commitment to improving public health services and IT infrastructure.

• 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.