Bureau of Health Devices and Technology (BHDT) has a New Name

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Bureau of Health Devices and Technology (BHDT) has a New Name

Ethics & Jurisprudence, Radiation Physics, Radiobiology & Radiation Protection | Hariette A.W. | August 31, 2011 at 21:32

The Bureau of Health Devices and Technology (BHDT), one of the agencies of the Department of Health (DOH) that has regulatory functions over radiation devices and radiation facilities here in the Philippines, has a new official name – Center for Device Regulation, Radiation Health, and Research (CDRRHR).

This change of name was mainly due to the amendment of the Republic Act (RA) 3720 of the Republic of the Philippines with the passage of a new law , RA 9711 – “The Food and Drug Administration (FDA) Act of 2009”. Actually, the FDA Act of 2009 affected two existing DOH agencies – Bureau of Food and Drugs (BFAD) and BHDT.

With FDA Act of 2009, major functions of the Center for Device Regulation, Radiation Health, and Research (CDRRHR) are emphasized.

major functions of the Center for Device Regulation, Radiation Health, and Research (CDRRHR)

With this change, FDA has planned medical device regulatory system for the concerned groups such as the Manufacturers, the Distributors/importers, the Distributors/wholesalers and the Retailers. In addition to this, requirements for Registration of Medical Devices have also been “amended” such that contents of design verification and validation documents, risk assessment, clinical evidence, biological evaluation, device description and manufacturer’s information will vary depending on the classification of the device being applied for.

Source: http://www.who.int/en/

Note: Special thanks to Mark for informing me about the new name of BHDT.

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Tags: and Research, bfad, bhdt, Bureau of Health Devices and Technology, CDRRHR, Center for Device Regulation, FDA Act of 2009, RA 3720, RA 9711, Radiation Health, Republic Act 3720, The Food and Drug Administration (FDA) Act of 2009

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