Regulatory Updates

Regulatory Affairs Update: Thailand

Thailand: FDA Announced a Comprehensive Guide to Evaluating Academic Documents and Medical Device Licensing Inspections

Thai Food and Drug Administration (FDA) announced the Criteria, Methods, and Conditions for Evaluating Academic Documents, Analysis, Establishments Inspection or Inspections for Consideration and Permission of Medical Device Licensing, B.E. 2567 (2024). The goal is to streamline the licensing process for medical devices while maintaining high quality, efficiency, and safety

Regulatory Affairs Update: Thailand

Thailand: Draft Announcement on The Highest Rates of Expenses for Document Evaluation, Analysis, Business Establishment Inspection, or Medical Device Inspection for Monitoring, Auditing, or Surveillance to Control the Manufacturing, Import, and Sale of Medical Devices

The Thailand Food and Drug Administration (TFDA) issued a draft announcement governing the highest rates of expenses for document evaluation, analysis, business establishment inspection or medical device inspection monitoring, auditing, or surveillance to control the manufacturing, import, and sale of medical devices. This announcement will be effective after its issuance

Regulatory Affairs Update Thailand

Thailand: Draft Announcement on the Expenses for Document Evaluation, Analysis, Establishment Inspection, or Medical Device Inspection for Monitoring, Auditing, or Surveillance to Control the Manufacturing, Import, and Sale of Medical Devices

The Thailand Food and Drug Administration (TFDA) issued a draft announcement governing the expenses for document evaluation, analysis, establishment inspection, or medical device inspection for monitoring, auditing, or surveillance to control medical device manufacturing, import, and sale. This announcement will be effective 90 days after issuance in the Royal Gazette.

Regulatory Affairs Update: Malaysia

Malaysia: Encouragement to Submit Medical Device Re-Registration Applications One Year before the Certificate Expiration Date

Per the MDA/GL/08 entitled “Guidelines for Re-Registration of Registered Medical Devices,” applications for medical device re-registration are to be submitted online via the MeDC@St 2.0+ system one year before the certificate expiration date. The re-registration button will become available in the system one year prior, allowing establishments to submit their

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