• 2020-02-12 14:24:17

Just recently, a number of advisories concerning recalls of healthcare products were observed to increase. These advisories being referred to are a result of product recalls conducted in accordance with the guideline issued in mid of 2016.

• 2020-02-12 14:22:55

At the end of August, the China Market Supervision Administration (the leader institute of NMPA) has officially published the “Measures for Monitoring and Re-evaluation of Adverse Events of Medical Devices”.

• 2020-02-12 14:21:58

Last August, NMPA has issued a draft entitled “Measures for the Supervision and Administration of the Local Authorization Agent for Imported Medical Device” in order to ensure the safety and effectiveness thereof. The draft was also aimed at regulating the behavior of local authorized agents of imported medical devices.

• 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.

• 2020-02-12 14:18:59

In carrying out the medical device registration process in Indonesia the applicant must fulfill administrative and technical documents requirements.

• 2020-02-12 14:17:57

The update guidance includes "risk classification", "licensing of manufacturer", "Field safety corrective action", product registration"... and other registration related documents.

• 2020-02-12 14:16:42

• 2020-02-12 15:57:24

It is divided into 12 distinct parts, wherein the 3rd to 11th parts include technical documentations with the following main sections (a) the safety& effectiveness checklist (b) summary of the device (c) research study (d) manufacturing process, (e) clinical evaluation study (f) risk management report (g) technical requirements (h) test reports, and (i) IFU and labels.

• 2020-02-12 15:56:38

The National Medical Product Administration (hereinafter referred to as NMPA) has released a list of medical device industry standards covering the new and amended standards from August 7th. Notable standards included in this exhaustive list, among others, include "Electrical safety standards for medical electrical equipment",

• 2020-02-12 15:55:53

On August 29, a new notice from the department of drug registration has revealed that CFDA has changed to its official English name to ‘National Medical Product Administration (NMPA)’ which was also adopted by the medical device registration system. It can be seen that NMPA is already an officially recognized English name.