Medical Device Act 2008

A History of Medical Device Regulation and Oversight in …

https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states

Authorized electronic registration of medical device firms Established the Office of Combination Products 2007: Food and Drug Administration Amendments Act (FDAAA) Reauthorized the medical...

Medical Device Safety | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/medical-device-safety

Medical Device Safety The FDA monitors reports of adverse events and other …

Medical Device Regulation Act - Wikipedia

https://en.wikipedia.org/wiki/Medical_Device_Regulation_Act

Overview of the Safe Medical Devices Act of 1990

https://www.drugwatch.com/fda/safe-medical-device-act/

Medical devices, as regulated by the FDA, were originally defined in the FD&C Act as: “Any instrument, machine, contrivance, implant, in vitro reagent that's …

(Unofficial Translation) - Ministry of Public Health

https://www.fda.moph.go.th/sites/fda_en/Shared%20Documents/Med%20ACT_2008.pdf

(10) medical devices which must be sold only to medical centres or medical and public health practitioners, as well as the rules, procedures and conditions for selling medical …

Thailand Medical Device Registration and Approval

https://asiaactual.com/thailand-3/medical-device-registration/

The regulatory process is based on the Medical Device Act B.E. 2551 (2008) and updated by the Medical Device Act/Ordinance B.E. 2562 (2019) (Issue 2). New regulations …

Thailand Implements New Medical Device Regulations

https://asiaactual.com/blog/thailand-implements-new-medical-device-regulations/

Thailand Implements New Medical Device Regulations. Published on: February 26th, 2021. On February 15 th the Thai FDA published significant new guidance governing the classification, technical …

Thai Medical Device Act, B.E. 2551 (2008) – idcOnic Co., Ltd.

http://www.idconic.com/about-idconic-import-export-thailand/doing-business-in-thailand/thai-laws-regulations-medical-devices-index/thai-medical-device-act-b-e-2551-2008/

A specifications declaration under the Medical Device Act B.E. 2531 (1988) made prior to the effective date of this Act shall continue to be valid for an additional period of two years …

THAILAND: ThaiFDA Issues the Amended Medical Device Act …

https://www.qualtechs.com/en-gb/article/384

Medical Device Act (Issue 2) B.E. 2562 (2019), enacted by the King Rama 10th, by and with the advice and consent of National Legislative Assembly, is divided into …

MEDICAL DEVICES ACT - BDA

https://bda.bg/images/stories/documents/legal_acts/ZMI_en_20160308.pdf

Art. 3. The requirements for medical devices provided for in the present Act also apply to: 1. accessories to the devices; 2. devices including as an integral part a substance which, if …