Thailand Implements Enhanced Quality Standards for Medical Device Industry

The Thai Food and Drug Administration (FDA) has announced new regulatory frameworks designed to elevate the quality of medical devices in Thailand. As part of this initiative, two important notifications have been issued: the Good Manufacturing Practice (GMP) and the Good Importing and Sales Practice (GISP), both taking effect in 2023.

Under the new GMP Notification, from July 2024, new device makers of moderate to high-risk medical devices are required to comply with stringent quality measures, including obtaining the GMP, TCAS 13485, or ISO 13485 Certificates. Device makers focused on low-risk devices are also directed to enhance their manufacturing processes according to these standards, although obtaining the certifications is not compulsory for them.

Additionally, existing manufacturers that already hold GMP Certificates under prior standards are permitted to continue operations without new certifications, provided they align with the updated requirements within specified grace periods.

On the import and sales side, the GISP Notification stipulates that beginning January 5, 2025, importers and sellers must start updating their quality systems to meet the new standards too, with a deadline for full compliance by January 2029.

These regulatory updates signify a major step forward in Thailand’s commitment to ensuring the safety and quality of medical devices, aligning with international best practices and bolstering consumer confidence in the healthcare sector.


Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

Source used in the article: https://insightplus.bakermckenzie.com/bm/healthcare-life-sciences/thailand-thai-fda-issues-regulations-on-quality-systems-for-medical-devices#:~:text=From%20July%202024%2C%20new%20manufacturers,or%20the%20ISO%2013485%20Certificate).