The Food and Drug Administration (FDA) of the Philippines has released a draft Circular titled “Guidelines on the Inspection of Medical Device Establishments” to enhance regulatory oversight and ensure continued compliance with safety and quality standards. This establishes uniform inspection procedures, documentary requirements, and evaluation criteria for manufacturers, traders, distributors, and retailers of medical devices, in alignment with Administrative Order No. 2024-0015, PNS ISO 13485:2019, and WHO TRS 1025 Annex 7.
Scope
Summary of the draft Circular issued by the Philippine FDA, detailing the proposed framework for inspection of medical device establishments to strengthen compliance and align with international quality system standards.
Key Highlights
Purpose of the Circular
- To establish clear inspection and evaluation guidelines for medical device establishments
- To harmonise inspection processes with global standards and best practices
- To reinforce regulatory control in accordance with AO No. 2024-0015, PNS ISO 13485:2019, and WHO TRS 1025 Annex 7
Coverage
The guidelines apply to all medical device manufacturers, traders, distributors, and retailers operating in the Philippines.
Regulatory Alignment
The Circular emphasises consistency with international quality management frameworks, promoting transparency and predictability in regulatory enforcement.
Attachment
See the draft Circular titled “Guidelines on the Inspection of Medical Device Establishments” (provided in English). [PDF]
Effective Date
To take effect upon final issuance of the Circular (exact date to be confirmed by the Philippine FDA).
Implications to Clients
The FDA invites comments and feedback from medical device establishments and industry stakeholders. Companies are strongly encouraged to review the draft and submit their input to ensure practical implementation and alignment with business operations. This consultation phase will shape the final version of the Circular.
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