Restructured Payment Collection for Applications with the Radiation Regulation Division (RRD) of the Center for Device Regulation, Radiation Health and Research (CDRRHR)

radiation regulation

The Philippines Food and Drug Administration (FDA) has launched a new policy and procedure, under FDA Circular No: 2018-004,  relating to the implementation of the FDA Payment Portal for applications made to the Radiation Regulation Division (RRD) of the Center for Device Regulation, Radiation Health and Research (CDRRHR).

Background:
Pursuant to the issuance of Philippines FDA Circular No. 2017-010 dated 11 September 2017, the Food and Drug Administration (FDA) implemented a new policy and procedure on the collection of payments for applications with the agency, particularly applications made with the Radiation Regulation Division (RRD). The new policy and procedure, under the FDA Circular No: 2018-004, offers more payment option, thereby improving convenience and efficiency of transactions.

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2018-10-24T14:35:40+08:00 August 3rd, 2018|News & Events|

Indonesia: Stipulation of Circulation Permit and Circulation of Medical Devices Containing Mercury

obsolete

Medical devices containing mercury may only be circulated or traded in Indonesia until December 31, 2018. Marketing authorization licenses for such devices that are valid until after December 31, 2018 will be declared no longer valid after that date.

Based on the law no. 11 of 2017 on the Minamata Convention on Mercury, mercury and its compounds are considered very dangerous to health and the environment because of their toxicity, persistence in the environment, bioaccumulation and ability to travel in the atmosphere. In order to ensure the creation of a clean and healthy environment for the people of Indonesia, and to protect future generations from the negative impact of mercury, the Indonesia Ministry of Health issued circular letter no. HK.02.02/V/0720/2018 regarding the circulation of medical devices containing mercury.

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2018-10-24T14:36:28+08:00 August 3rd, 2018|News & Events|

Good Distribution Practice for Medical Devices in Thailand

Good Distribution Practices

The Good Distribution Practices regulation in Thailand will apply to manufacturers, importers, and distributors and will require them to gain Good Distribution Practices certification to ensure quality, safety, and performance throughout the supply chain.

The Thailand Public Health Ministry has published a notification in the Royal Gazette regarding the Good Distribution Practices (GDP) regulations for Medical Devices B.E 2561.

The GDP regulations will apply to manufacturers, importers, and distributors and will require them to gain GDP certification to ensure quality, safety and performance throughout the supply chain.

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2018-10-24T14:37:02+08:00 August 3rd, 2018|News & Events|

Telehealth in Singapore

telehealth

In Singapore, telehealth devices must undergo product registration and obtain market clearance prior to importation. The process for product registrations is the same as that currently used in the healthcare industry.

The introduction of telehealth technology has revolutionized the healthcare industry in Singapore. With this technology, patients located in rural areas can be assessed remotely by doctors and can manage and monitor their health without attending a hospital. According to recent news, a trial concluded at the end of 2017 by the National University Health System (NUHS) was the first to utilize telehealth technology in Singapore.

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2018-10-24T14:37:41+08:00 August 3rd, 2018|News & Events|