• 2026-10-27 04:18:58

The Food and Drug Administration of the Philippines (PFDA) has released a draft FDA Circular proposing detailed guidelines for medical device labeling in the Philippines. The draft provides more specific requirements on labeling content and placement, device-specific labeling, electronic labeling, and regulatory actions for non-compliance. It also proposes a two-year transition period for medical devices already registered and available in the Philippine market. While the Circular remains in draft form, it reflects PFDA's direction toward more detailed and specific medical device labeling requirements.

• 2026-10-26 09:52:44

The Food and Drug Administration of the Philippines (PFDA) has circulated a revised draft Circular proposing updated regulatory guidelines for Medical Device Software (MDSW), including AI-enabled MDSW. The draft outlines software qualification criteria, risk-based classification, product authorization pathways, and technical documentation requirements for initial and renewal applications. It also introduces AI-specific requirements covering clinical validation, cybersecurity, risk management, and post-market monitoring. The proposed guidelines aim to strengthen the safety and performance of MDSW throughout its lifecycle. The Circular remains in draft form and is not yet effective.

• 2026-09-21 03:23:41

The Philippine Department of Health has released a proposed Administrative Order establishing Good Manufacturing Practice (GMP) guidelines for local medical device and IVD medical device manufacturers. The proposed Order adopts PNS ISO 13485:2019 as the Food and Drug Administration (FDA)'s official GMP guideline and applicable PNS ISO 14644 standards for clean rooms. A two-year transitory period is proposed to allow affected manufacturers to comply with the new requirements once the Order takes effect.

• 2026-07-27 03:42:33

The Philippine FDA has issued a draft Circular proposing a comprehensive risk-based framework for post-approval variations of medical and health-related devices. Key proposed changes include the introduction of risk-based variation classifications, a dedicated variation pathway for medical device software (MDSW), single variation applications for eligible multiple product authorizations, updated submission procedures, and enhanced post-market responsibilities for Marketing Authorization Holders (MAHs) and retailers. The draft also provides guidance on timelines, fees, and regulatory enforcement to support a more standardized variation process.

• 2026-05-27 01:54:19

Effective May 6, 2026, Administrative Order No. 2025-0030 establishes a mandatory Post-Marketing Alert System (PMAS) for medical devices in the Philippines, aligning national policy with the ASEAN Medical Device Directive. The order requires manufacturers, traders, and distributors to maintain strict traceability records, report adverse events within 48 hours to 30 days, and implement Field Safety Corrective Actions to mitigate risks. A one-year transition period for industry compliance has officially commenced.

• 2026-04-01 09:14:49

The proposed PFDA guidelines establish requirements for maintaining importation and distribution records and for reporting product complaints, adverse events, and field safety corrective actions for medical devices to ensure traceability and facilitate appropriate regulatory action. This article outlines the specific responsibilities, strict reporting timelines, and record-keeping mandates designed to protect public health throughout the device lifecycle.

• 2025-05-29 10:06:54

On April 28, the National Medical Products Administration (NMPA) issued the Guidelines for Quality Management of Online Sales of Medical Devices, which will come into effect on October 1, 2025.

• 2025-03-25 10:37:19

The Thai FDA updated its change notification guidelines, effective 15 January 2025, focusing on model additions/removals and importer/manufacturer info updates for both IVD and non-IVD devices. The update allows modifications to groupings when adding or removing products within the same application. Additionally, adding models is now classified as a Major Change, requiring an extensive documentation.

• 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.

• 2024-12-16 08:32:04

Following the Industry Consultation held from 25 January to 10 March 2023 and Sandbox Phase conducted from October 2023 to July 2024, the CSA, in collaboration with MoH, HSA, and Synapse launches the Cybersecurity Labelling Scheme for Medical Device [CLS(MD)] for public applications along with a set of publications as guidelines for the applicants. The program opens for voluntary enrollment on 16 October 2024 as part of Singapore’s effort to enhance cybersecurity awareness.

Manufacturers who wish to pursue one of the 4 cybersecurity levels should apply to Cybersecurity Certification Centre (CCC) through GoBusiness Licensing Portal https://www.gobusiness.gov.sg while inquiries can be sent to email: cls_md@csa.gov.sg.