INDONESIA: REGULATION OF THE MINISTER OF HEALTH NO. 3 YEAR 2024 – ON INDONESIA'S HALAL MEDICAL DEVICE MANUFACTURING - August/September 2024

• 2024-09-17 03:17:46

Indonesia's Ministry of Health has issued Regulation No. 3 Year 2024 as a new derivative to the previous halal regulations on medical devices, providing a more specific outline on the mandate for medical device halal certification. This regulation introduces stringent requirements for manufacturing, labeling, and material disclosure.

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USA: US FDA Voluntary Medical Device Manufacturing and Product Quality Pilot Program – June 2022

• 2022-06-29 03:18:32

The U.S. Food and Drug Administration has released a new draft guidance to further a voluntary program aiming to improve quality-related processes in medical device manufacturing. The concept comes from the Medical Device Innovation Consortium (MDIC), which assesses the capability and performance of key business processes using a maturity appraisal model tailored to the medical device industry. The overall stated goal is to enhance the quality processes and to improve the overall medical device quality, as to ultimately ensure better patient treatment outcomes.

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THAILAND: Thai FDA Updated Guidelines for Medical Device Manufacturing, Importation and Distribution Records – June, 2021

• 2021-08-02 06:16:13

Thai FDA progressively issues series of guidelines to enhance the new medical device act. This month will be focusing on the latest requirement on medical device manufacturing, importation, and distribution records or report preparation.

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