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No. Title Status Download
1Medical Devices Act, B.E.2551 (2008) and (No. 2), B.E. 2562 (2019)
2Re: Medical device import facilities, B.E. 2552 (2009)
3Re: Classes of medical devices or medical devices for which manufacturers or importers are required to obtain a license, B.E. 2563 (2020)
4Re: Classes of medical devices or medical devices in respect of which manufacturers or importers are required to make a notification, B.E. 2563 (2020)
5Re: Rules, procedures and conditions on display of labels and medical device package inserts, B.E. 2563 (2020)
6Re: Rules, procedures and conditions for preparation of reports on medical device malfunctions or adverse events occurring to consumers and reports on field safety corrective actions for medical devices, B.E. 2563 (2020)
7Re: Risk classification of medical devices, B.E. 2562 (2019)
8Re: Classes of medical devices or medical devices of which manufacturers or importers are required to declare specifications (no. 2), B.E. 2563 (2020)
9Re: Prescribing rules, procedures and conditions on registration of medical device manufacturing establishments, B.E. 2552 (2009)
10Re: Specification of standards and evaluation of test kits and reagents related to diagnosis of sars-cov-2 (virus causing covid-19) infection, B.E. 2564 (2021)
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FOOD AND DRUG ADMINISTRATION

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