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USA: Post-Approval Studies Program

USA: Post-Approval Studies Program

  • 2021-04-26 02:48:33

In order to ensure the safety and effectiveness of medical devices, the FDA has the Post-Approval Studies Program for 3 kinds of applications. There are Premarket Approval (PMA), Humanitarian Device Exemption (HDE), and Product Development Protocol (PDP). Applicants for these categories should follow the conditions from Post-approval studies to maintain product legality.

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USA: 522 Postmarket Surveillance Studies Program

USA: 522 Postmarket Surveillance Studies Program

  • 2021-04-26 02:44:41

The Center for Devices and Radiological Health (CDRH) has established an internal tracking system for 522 postmarket surveillance studies, where each product applicant can view the status and timeline of their products when the FDA requires the 522 postmarket surveillance study.

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SINGAPORE: HSA Shares Future Plan of UDI System in Singapore

SINGAPORE: HSA Shares Future Plan of UDI System in Singapore

  • 2020-12-24 11:09:03

Health Sciences Authority (HSA) – Medical Devices Branch had organized a webinar regarding an introduction to Medical Device Unique Device Identification (UDI) System last October 19, 2020. In addition, the webinar includes the phased implementation plan for UDI in Singapore.

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CHINA: NMPA Issued the Draft for UDI Rules of Medical Device- October 2018

CHINA: NMPA Issued the Draft for UDI Rules of Medical Device- October 2018

  • 2020-02-12 14:21:01

In order to reinforce the supervision and management of the development, production, operation and use of medical devices, NMPA (National Medical Product Administration) has issued the “Draft of UDI Rules for Medical Device” at the end of August with the primary objective of establishing a unique identification system (UDI) for medical devices. This regulation applies to medical devices that are sold and used in China.

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