• 2021-03-22 01:22:59

The Medical Device Branch (MDB) of the Health Sciences Authority (HSA) has released a draft document entitled “Regulatory changes for software-based medical devices” and changes effective from 25 February 2021.
The purpose of the guideline is to update the classification of software-based medical devices according to the risks of harm from software and outlines transition arrangements available for devices that may need to be reclassified or that qualify for an exemption or exclusion from the Therapeutic Goods (Medical Devices) Regulations 2002.

• 2020-06-11 09:48:40

NMPA publishes a clear guidance to regulate the raw material change in medical device. In this guidance, it points out three major changes on material component and how to perform the risk assessment on raw material change.

• 2020-04-14 03:44:26

The Health Sciences Authority (HSA) of Singapore has published an updated GN – 21 R4.6: Guidance on Change Notification last February 2020, effectively renaming it to GN – 21 R4.7.

• 2020-02-21 07:07:01

For both GN-21 and GN-34, HSA added guidance regarding notification of software changes in In Vitro Devices (IVD) .

• 2020-05-06 07:05:38

The Medical Device Market of the Philippines offers Foreign Manufacturers a wealth of opportunities, due to the strong demand for innovative devices and the market’s extreme dependency on foreign imports. With local production covering less than 10% of the national demand and being restricted to a small variety of products, the Philippines promise favorable conditions for foreign companies interested in expanding to Asia.

• 2020-05-06 05:29:23

HSA has conducted an industry briefing last March 28, 2019 regarding the guidance revision for Change Notification (CN) which aims to address typical concerns that results in confusion among stakeholders. Additional updates on the requirements for CN applications were also added.

• 2020-02-12 14:07:31

In November, MDA had issued three major guidance documents, two of them being revised editions. One of these two is the 3rd revised edition of Guidance Document for Change Notification for Registered Medical Device in Malaysia.

• 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.

• 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 07:30:40

Medical Device Authority (MDA) of Malaysia has made a change in event date of the Malaysia Medical Device Expo 2018. Initially, it was set to take place on 18th to 20th April 2018, however, MDA has very recently made a change for the event to be held from 23rd to 25th October 2018 at PWTC, Kuala Lumpur.