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Thailand: Thai FDA Announcement: Exemption of Prescribed Information, Documents, and Evidence for Licensed and Notified Medical Devices, 2024 - August/September 2024

Thailand: Thai FDA Announcement: Exemption of Prescribed Information, Documents, and Evidence for Licensed and Notified Medical Devices, 2024 - August/September 2024

  • 2024-09-17 02:22:43

The Thai FDA has announced significant regulatory changes to accelerate the approval process for medical device manufacturing and importation. Effective June 6, 2024, these changes aim to reduce redundancy in documentation without compromising product safety or quality. This streamlined approach is expected to foster innovation, attract foreign investment, and enhance Thailand's position as a regional healthcare hub.

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THAILAND: GUIDELINE FOR EVALUATING DOCUMENTS FOR CLASS 2,3,4 MEDICAL DEVICES THROUGH CONCISE EVALUATION AND RELIANCE PROGRAM - APRIL/MAY 2024

THAILAND: GUIDELINE FOR EVALUATING DOCUMENTS FOR CLASS 2,3,4 MEDICAL DEVICES THROUGH CONCISE EVALUATION AND RELIANCE PROGRAM - APRIL/MAY 2024

  • 2024-05-07 08:47:38

Thai FDA has replaced its previous criteria for evaluating medical devices via expedited routes with new guidelines published in 2024. The aim is to streamline the evaluation process for Licensed and Notified medical devices (Class 2,3,4) while ensuring quality, efficiency, and safety. The announcement outlines criteria, documents required, and regulatory procedures for the Concise Evaluation and Reliance Program routes under expedited route review.

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PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices – March/April 2023

PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices – March/April 2023

  • 2023-03-27 08:52:43

PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.

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THAILAND: Medical Device Categories Applicable for Full CSDT Submission and Partial 2 Submission Route – January/February 2023

THAILAND: Medical Device Categories Applicable for Full CSDT Submission and Partial 2 Submission Route – January/February 2023

  • 2023-01-19 01:28:15

As we are easing into the first quarter of 2023, we are thus simultaneously entering into the last phase of Thai FDA grace period regarding the transition to the risk-classification approach. Thus, Thai FDA has published a summary of the medical device categories on their official website instructing medical device registration via Full CSDT submission and Partial 2 Submission route.

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