The Thai Food and Drug Administration (FDA) has introduced two critical notifications to enhance quality standards across the medical device sector. Here’s what you need to know:
Good Manufacturing Practice Notification (GMP) B.E. 2566 (2023) – Starting July 2024, new manufacturers of moderate to high-risk medical devices are required to comply with stringent standards. Manufacturers must obtain either a GMP Certificate, a Thai Conformity Assessment Standard – TCAS 13485 Certificate, or an ISO 13485 Certificate. For low-risk devices and veterinary medical devices, manufacturers must upgrade facilities to meet new quality system requirements, although certification is not mandatory.
Good Importing and Sales Practice Notification (GISP) B.E. 2566 (2023) – This regulation takes effect on January 5, 2025, setting forth new quality system requirements for importers and sellers of medical devices. Full compliance is mandated by January 2029.
Current certificate holders under older standards can continue operations post-July 2024 without new certifications but must align with the updated GMP standards within specified grace periods.
For more details, visit the Thai FDA’s site: moph.go.th
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