• 2020-02-13 06:13:18

Health Sciences Authority announces changes to the regulatory process for medical devices, including faster market access for lower risk devices, clearer regulatory controls for De novo device and high risk device, strengthen Post-market measures. 

• 2020-02-14 04:17:45

During the early week in May, the Hainan Government has issued a further notice for “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. This is applicable to medical devices that are urgently needed for clinical purposes (hereinafter referred to as "emergency devices").

• 2020-02-14 04:08:31

Outcomes of these consultation sessions have been consolidated and new revisions to the existing guidance documents and issuance of new guidance documents are to be carried out in stages, after this.

• 2020-02-14 04:06:17

Vietnam Ministry of Health released the draft decree mention some points of Medical Device Management under Decree 36/2016/ND-CP. After the detailed analysis, Qualtech has outlined five major differences between the new and previous version of regulations:

• 2020-02-14 07:28:51

HSA held a briefing in order to present key proposal changes in the existing regulation. The said event focused on six proposed key changes to current medical device regulations.

• 2020-02-14 07:45:46

The Medical Device Authority (MDA) has issued a new Circular Letter on March 5th 2018 bearing new requirements for the licensing and medical device registration for Original Equipment Manufacturer (OEM) in Malaysia. This circular letter identifies who construes as an OEM and the reason why OEMs are not regulated under the Medical Devices Act 2012 (Act 737) till far.

• 2020-02-14 07:50:54

The Unique Device Identification (UDI) system is a set of alphanumeric codes that serves to enhance monitoring activities for medical devices. It consists two parts: (1) UDI (an array of alphanumeric codes) and (2) UDI carrier which come in three distinct types: (a) QR code, (b) Bar code, or (c) RFID/NFC.

• 2020-02-14 14:47:05

Indonesia's Ministry of Health (MoH) has enacted a new regulation, Permenkes No. 62 Year 2017, concerning Marketing Authorization of Medical Devices, In Vitro Diagnostic Medical Devices and Household Health Supplies on January 13, 2018.

• 2020-02-14 14:44:06

The CFDA has approved "The Administration Regulation for Online Medical Device Sales" (hereinafter referred to as the “Regulation”) proposed last November 7 2017, and will be fully implemented on March 1 2018. A total of 50 Clauses, including legislative purposes and scope, are outlined in the Regulation.

• 2020-02-14 14:54:42

In order to enhance the inspection of imported drugs and medical devices, China Food and Drug Administration (CFDA) has issued “Draft of Regulations for The Administration of Overseas Inspection of Drug and Medical Devices”. It is currently looking for public comments until January 24, 2018.