Nutrition labeling is not required for the following categories of … A total of 85 articles are in the new Act, of which the highlights are outlined below: Under the current Act, only entities who engage in actual production and final release of the product can submit a registration application as the legal manufacturer. Within the Ministry of Health and Welfare, the Taiwan Food and Drug Administration (TFDA) was established in 2010 to oversee food, drug, and medical device safety and quality. 31, 2018, Taiwan FDA issued an announcement detailing the revision of "Requirements for Prepackaged Food Nutrition Labeling".The updated standard entered into force on the date of release, which applies to all prepackaged food (excluding those are exempted) sold in Taiwan, including imported food, health food and special nutrition food. 2. The new Act will authorise TFDA to request medical device dealers to submit periodical safety monitoring reports for certain high-risk medical devices (to be announced). [2][3][4][5][6] It is part of the Ministry of Health and Welfare. Thus our people’s wellbeing can be assured. You can access 3 more original regulations if one of Learn from our experts through live events. In addition, we held training courses for the industries so they could learn and follow the latest ICH guidelines. TFDA has been joining ICH related events for more than 10 years since 2008. importers and downstream users to effectively manage their responsibilities. The Ministry of Health and Welfare (MOHW) performs on-site inspection for local manufacturers and also reviews Quality System Documentation (QSD) provided by foreign manufacturers. Level 8, 1 Chandos Street, St Leonards NSW 2065 Australia, Re-scheduling / Re-classification Services, Biosimilar & Biotechnology Medicine Development, Authorised Representation, Sponsorship & Distribution Management, Reimbursement – Strategy, Advice and Submissions, Upcoming update to the Taiwan FDA Medical Devices Act, TGA deploys Post Market Review Compliance Dashboard, TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates, TGA will require DOC’s to be submitted for Class I ARTG registrations, Your guide to claiming temporary exemption from TGO91/92 compliance. We have deep expertise with a range of product types, including combination and borderline products. Taiwan’s Pharmaceutical Affairs Actregulates the administration of pharmaceutical affairs, which includes drugs and medical devices, pharmaceutical firms, pharmacies, and other relevant matters. Under the new law, manufacturers, device dealers (including local distributors) and medical institutions will be required to establish and maintain a traceability system for high-risk devices (likely Class III). © 2020 Brandwood CKC. Certain clauses in the existing Medical Device Good Clinical Trial Practice (GCP) will be incorporated into a new Chapter in the Act, which will mandate the reporting obligations for any adverse events occurred during the clinical trial period. Taiwan FDA; Taiwan Medical Device Registration. Meet our MDR team and get free educational resources on the MDR. In the future, TFDA will continue to actively participate in the ICH related events to construct a regulatory environment that complies with the ICH guidelines. A platform of digital products to improve, simplify and automate RA/QA activities, The latest industry news and insights from our global team. We understand you need a commercial approach which delivers viable options. across Chemical, Food, Cosmetic and Agrochemical industries. ADD : No.161-2, Kunyang St, Nangang District, Taipei City 115209, Taiwan (R.O.C. Taiwan's classification system is similar to the system used by the US Food and Drug Administration. Application forms could be downloaded via TFDA website. All Rights Reserved. If you are a foreign manufacturer supplying Class III products to Taiwan, it may be the time to revisit the agreement with your local distributors to ensure the agreement aligns with the upcoming regulatory requirements. ; Under the MOHW, the Taiwan Food and Drug Administration (TFDA) is Taiwan’s equivalent of the U.S. FDA.All imported medical devices must obtain a registration certificate from the TFDA. View All. This also shows that our pharmaceutical products possess very high quality, and have been recognized by international standards. View All, Our global consulting team works from 20+ offices on six continents. A business which is currently only engaged in maintenance work will also need to comply with the relevant responsibilities outlined in the new Act for “medical device dealers”, including obtaining a business permit as a medical device dealer, having a good distribution practice in place for certain high-risk products that are announced by the authority. The new Act extends the definition of “manufacturers”, mandates the requirements to maintain traceability data, implements an online listing system for certain low-risk devices, adds management requirements for clinical trials, and strengthens postmarket surveillance on product safety. 31, 2018, Taiwan FDA issued an announcement detailing the revision of "Requirements for Prepackaged Food Nutrition Labeling". It is part of the Ministry of Health and Welfare. Rd., Taipei 11557, Taiwan. ). Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. It is mainly formulated to align the Act with global practices while incorporating certain requirements that are not currently in the Pharmaceutical Affairs Act but stipulated in other TFDA regulations/guidance. Comparison of Nutrition Label Requirements for Common Food in Mainland China, Hong Kong and Taiwan, Taiwan to Strictly Regulate Food Labeling Claims, Advertisement and Promotion, Revised Regulation of Food Allergen Labeling in Taiwan, China Approves 42 National Food Safety Standards (GB), South Korea Revises Labeling Requirements of Food, South Korea Consults on Revising the Recycling Symbols on Food Packing Materials, South Korea Revises Food Code: Amendments to Home Meal Replacement and CBD, Tmall Global Releases Quality Management Standards for CBEC Products Including Infant Formula, Health Food and Pet Food, China Consults on 18 Food Safety National Standards, involving FCM and Food Additives, China Publishes New Guidelines on Health Food Testing and Assessment. professional team backing up ChemLinked, offers compliance solutions to assist global manufacturers, your friends are successfully invited and register on You should not rely on this information, and you should seek specific advice for your particular business needs.Where indicated, certain content has been sourced from third parties; we have not independently verified it. It is believed that these regulatory updates will help accelerate product launch period to benefit patients while improving the management system of medical devices in Taiwan. [9], Food and Drug Administration, Ministry of Health and Welfare (Republic of China), "OPINION: Towards Easing Restrictions on Organic Food Imports in Republic of China", "2017 PIC/S Committee Meeting and Seminar conclude successfully in Republic of China with spectacular results", "ICH Advances Guidance, Adds New Members", https://www.fda.gov.tw/ENG/aboutFDAContent.aspx?id=23, https://en.wikipedia.org/w/index.php?title=Food_and_Drug_Administration_(Taiwan)&oldid=969083893, Articles containing Chinese-language text, Official website different in Wikidata and Wikipedia, Creative Commons Attribution-ShareAlike License, Bureau of Food Safety, Bureau of Pharmaceutical Affairs, Bureau of Food and Drug Analysis, Bureau of Controlled Drugs, This page was last edited on 23 July 2020, at 08:52. Through the collaborations between government and industry, high-quality drugs could be manufactured. The Taiwan FDA had published an Administrative Guidance of UDI on Oct. 30th, 2015; which is mostly harmonized with the UDI requirements of the IMDRF and US FDA. products. ICH was founded in April 1990 by the representatives of the regulatory authorities and industry associations from Europe, Japan and the US. ), Regulations on Prepackaged Food Products Exempted from the Nutrition Labeling(PDF), Regulations on Prepackaged Food Products Exempted from the Nutrition Labeling(WORD). All manufacturers planning to sell a medical device in the Taiwan need to register their product with the Taiwan Food and Drug Administration (TFDA. Taiwan Food and Drug Administration (TFDA) has officially become one of the ICH pharmaceutical Regulatory Member at the International Council for Harmonization (ICH) Assembly meeting at Kobe, Japan, 7th June 2018. ChemLinked is a leading provider of Asia-Pacific regulatory information and market intelligence Taiwan Food & Drug Administration (TFDA), has been devoted to enhancing food safety and drug quality in Taiwan. On 1 January 2010, the consolation of Bureau of Food Safety, Bureau of Pharmaceutical Affairs, Bureau of Food and Drug Analysis and Bureau of Controlled Drugs to form the Republic of China Food and Drug Administration were completed. UDI is expected to become mandatory in phases from high to low-risk devices once the new Act is implemented. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. We are aiming to ChemLinked. Applications could be submitted by individuals. ConclusionWhile the new Act does not introduce substantial changes to the existing requirements, many clauses in the new Act “grant” the relevant component authorities to formulate detailed requirements and procedures in separate regulations or guidance, it is necessary to heed these upcoming changes to ensure that your premarket and postmarket procedures are kept up-to-date and in-line with the latest regulations. ADD : No.161-2, Kunyang St, Nangang District, Taipei City 115209, Taiwan (R.O.C. The current Act only requires a product traceability system to be established for certain drug categories as announced by the authority. The new Act separates regulations of medical devices from the current overarching Act, which governs both drugs and medical devices, the “Pharmaceutical Affairs Act” (“current Act”). Upcoming update to the Taiwan FDA Medical Devices Act. If you need assistance on TFDA applications, market entry strategy, or specific help with regulatory documentation or a compliance check please reach out. The current definition of “medical device dealers” only includes businesses which engaged in the wholesale, retail, import, export and rental of medical devices. Brandwood CKC is the premier regulatory, quality systems and reimbursement consultancy in Australia serving local and international healthscience innovators for more than 20 years.
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