• 2024-09-17 05:40:30

NMPA issued a notice that administrative paperwork for some registration matters will become electronic versions starting June 1, 2024.

• 2022-10-25 07:24:41

Requirements for pre-assessment of medical device / in vitro diagnostic medical device registration are revised by NMPA.

• 2022-01-26 08:31:11

Clinical trial data is one of the important supporting documents for evaluating the safety and effectiveness of medical devices. Standardizing the collection, sorting, analysis, and submission of medical device clinical trial data will not only improve the quality of clinical trial implementation and management but also assist the regulatory agency to understand and review the development of clinical trials quickly and efficiently.

• 2021-08-26 12:02:05

In light of the latest COVID-19 situation in Malaysia, MDA has published a guidance document on medical face masks and respirators. The MDA/GD/0033 explains the minimum requirements for labeling as well as the performance characteristics of face masks and respirators that need to fulfill.

• 2021-04-26 03:19:54

Asia Pacific forms one of the most promising dental device markets in the world. In this edition of QT Analysis, we look into the market size waiting for you to take advantage of and the requirements to register your dental devices in this region.

• 2021-02-19 09:51:48

Asia’s elderly population is set to see tremendous growth, coupled with a rise in various geriatric and non-communicable health issues. To tackle these problems, rehabilitative and assistive medical devices market show great potential to become a major medical device segment in various Asia countries. In this issue of QT Analysis, we look at the market size for rehabilitative and assistive medical device and their registration requirements in some major Asian countries.

• 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.

• 2020-02-13 05:54:53

With an aim to strictly adhere to the provisions set by the ASEAN Agreement on Medical Device Directive (AMDD), the PFDA has issued a 3rd draft on the Rules and Regulations for the Registration Application for In-Vitro Diagnostic (IVD) Medical Devices to be placed in the Philippine Market.

• 2020-02-13 06:23:56

MDA has released a Circular Letter at the end of May 2018 as a reminder notice on the complete enforcement of requirements for registration of medical device under Section 5 of Medical Device Act 2012 (Act 737), whereby no medical device can be allowed to be imported, exported or marketed in Malaysia unless it has been registered with MDA, according to this Act.

• 2020-02-14 07:47:54

The Guidelines released by the Department of Health concerning Medical Device Registration is in place to be officiated following its publication. This shall be implemented a year after its effective date. Delayed implementation allows sufficient preparation for applicants in securing technical documents crucial to the registration process.