Regulatory News - July/August 2024
August 12, 2024
FOOD/DIETARY SUPPLEMENTS- New limits for vitamins and minerals: from July 2nd, 2024 new increased limits for vitamins and minerals are effective. Read the article here: New limits for vitamins and minerals (https://dmse7.r.ag.d.sendibm3.com/mk/cl/f/sh/6rqJfgq8dINmODl9Dl333lSGW0N/rtP4nU54IOKx)
- FDA issued the updated list of allowed ingredients in food and dietary supplements. Read the article here: Updated List of Allowed ingredients (https://dmse7.r.ag.d.sendibm3.com/mk/cl/f/sh/6rqJfgq8dIPRQg3Ii4SazMaC9JP/-wztYriClGHx)
MEDICAL DEVICES
- Thailand will implement GDP (Good Distribution Practice) with a 3 years plan starting from January 1st, 2025. Read the article here: Thailand GDP for Medical Devices (https://dmse7.r.ag.d.sendibm3.com/mk/cl/f/sh/6rqJfgq8dIR6T8LSCNs8uxi7mcR/1sAhf_JJIXEU)
- List of recognized Regulatory Agencies has been issued indicating a list of accepted Foreign Agencies for Inspection or Certification of Medical Devices. Read Article here: List of Accepted Foregin Agencies (https://dmse7.r.ag.d.sendibm3.com/mk/cl/f/sh/6rqJfgq8dISlVadbghHgqYq3PvT/ri-urlQPneB3)
- Thailand implemented the "abridge" process simplifying the submission process in case of registration in approved Foreign Agencies. Read Article here: Abridged Program (https://dmse7.r.ag.d.sendibm3.com/mk/cl/f/sh/6rqJfgq8dIUQY2vlB0hEm9xz3EV/CmiLdRRzOaJh)
- New requirements for "responsible person" in case of medical device import license. Thai FDA set new requirements for the technical responsible of medical device import Companies. Read the article here: New requirements for technical responsible for Medical Device (https://dmse7.r.ag.d.sendibm3.com/mk/cl/f/sh/6rqJfgq8dIW5aVDufK6mhl5ugXX/PR31UgaaV3Fs)
- Foreign Business License open to Medical Device Manufacturer distributing their products in Thailand. A great opportunities for the sector. Read the article here: Foreign Business License in Thailand for the Medical Device Sector (https://dmse7.r.ag.d.sendibm3.com/mk/cl/f/sh/6rqJfgq8dIXkcxW49dWKdMDqJqZ/b7KScszQUIhu)
CUSTOM and TAX
- Prime Minister officially request strict controls on healthcare products import - Bulk and Corss border commerce. Read The Article here: Is cross-border going to an end? (https://dmse7.r.ag.d.sendibm3.com/mk/cl/f/sh/6rqJfgq8dIZPfPoDdwvsYxLlx9b/ECPhUqHsTnkZ)
- New Custom Regulation aimed to control Corss-border commerce: the Labubu case sparkle a reaction of Thai Authorities. Read the article here: New Crossborder Regulation in Thailand to Impact Cosmetic and Dietary Supplement Shipments (https://dmse7.r.ag.d.sendibm3.com/mk/cl/f/sh/6rqJfgq8dIb4hs6N8GLQUYThaSd/NFOsCFJe6OHT)
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