Regulations For more information. Regulation on Management of Safety Information Including Medical Device Side Effects, Etc. Registration Date 2016-04-30; Hit ...

Regulation on Management of Safety Information Including Medical Device Side Effects, Etc. Regulation on Management of Safety Information Including Medical ...

The purpose of this Act is to promote the efficient management of medical devices and further contribute to the improvement of national health.

The purpose of this Rule is to prescribe the matters mandated by the Medical Devices Act and the Enforcement Decree of that Act and matters necessary for ...

All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the ...

and management of medical device manufacturing/quality/safety (including safety management of post-market side effect, etc.; the same shall apply in this.

The Regulation (EU) 2017/745 on medical devices (1) requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP).

There are two regulatory authorities responsible for regulation of medical devices in Japan: the Ministry of Health, Labour and Welfare (MHLW) and the PMDA. The ...

This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. Title 21 · 803.40 – 803.42 · 803.50 – 803.58

In. 2005, the Korea Ministry of Food and Drug Safety enacted in regulations of medical device safety management that include adverse incident reporting and a ...