• 2020-02-21 07:22:04

Earlier in January 2020, MDA had released a revised Circular Letter No. 2 Year 2018, on the control of orphaned, obsolete and discontinued medical device healthcare and related facilities. There have been some revisions introduced to the definition of types of medical devices covered in this circular letter.

• 2020-02-21 07:21:24

MDA has introduced new revisions to the Guidance Document on Import And/or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education. All stakeholders are advised to take of these changes while making an application for the Notification of Medical Device for Demonstration purposes, to ensure a smooth process.

• 2020-02-21 07:20:48

The Ministry of Health (MoH) was recently notified by the MDA on a 'headphone' device that allegedly reduces and controls blood sugar levels, published through a local newspaper.

• 2020-02-21 07:19:49

CDSCO India has issued an extension for several types of medical devices to register for market authorization, some until January 2021 while the other types have until April 2021.

• 2020-02-21 07:17:09

HSA released a draft guidance for software regulation last December 2019. The draft includes detailed explanation of regulation from pre-marketing approval to post market monitoring of software devices. The Singaporean authority would like to ask for stakeholder comments before official implementation

• 2020-02-21 07:16:25

In order to maintain the safety and efficacy of a medical device, a surveillance system is needed. Therefore, medical device distributors in Indonesia are recommended to comply with CDAKB / Good Distribution Practice of Medical Device.

• 2020-02-21 07:14:51

Health spending is growing faster than the overall economy globally as well as in most countries. In this article, we are looking at the healthcare expenditure and medical device demand trends in China, Thailand, Malaysia and Singapore, to understand how their government are spending to improve the living standard of their citizens.

• 2020-02-21 07:12:37

On December 20, 2019, the NMPA issued an update of the Exemption List from Clinical Trials in China for Medical Device (hereinafter simply referred to as the “Exemption list"), which includes "medical devices" and "in vitro diagnostic devices".

• 2020-02-21 07:11:54

After publishing the guidance of clinical evaluation in the International Medical Device Regulators Forum (IMDRF), the NMPA has quickly released the revised guidance of clinical evaluation for China registration. This guidance is predicted to be implemented by 2021.

• 2020-02-21 07:11:04

On December 20, 2019, the NMPA has issued the so-called "Guidelines for Conditional Approval of Medical Devices " . The Guideline was officially implemented on the day of release and will help expedite the conditional approval of medical devices under certain circumstances.