• 2021-05-22 04:28:32

On April 20, 2021, Malaysia Medical Device Authority (MDA) published a revision list of Medical Device-Drug-Cosmetic Interphase (MDDCI) products. MDA has classified they regulated medical device and combination products that primary intended use of the device and the primary mode of action is to be used as a medical device.

• 2021-05-22 03:59:29

The Australian Therapeutic Goods Administration (TGA) has implemented reforms to the regulation of software based medical devices. These regulations commenced on February 25, 2021 for new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG). The clarification of the boundary for software-based products regulated as medical devices in Australia is important to ensure sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight. Certain software-based medical devices have been carved out (through either an exemption or exclusion) from the scope of the TGA regulation. The transition period (ending November 1, 2024) applies to sponsors of eligible medical devices already included in the ARTG, or included in the ARTG because of an application lodged before 25 February 2021.

• 2021-05-22 03:15:45

Thai FDA has publicized a series of regulations for Listing Medical Device (Class 1), fulfilling the completion of the transition from policy-based classification to risk-based classification. This marked a milestone for both establishments and the Thai FDA team.

• 2021-04-26 03:09:33

Medical Device Act, the act that separates medical devices from the genre of medicines under Pharmaceutical Affairs Act, will be fully implemented on May 1st, 2021. Along with Medical Device Act, Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License will come into force on the same date.

• 2021-04-26 02:33:36

On December 21, 2020, State Council in China announced the adoption of New Regulations on the Supervision and Administration of Medical Devices (Medical Devices Order. 739 of the State Council). Respectively on March 18, 2021, State Drug Administration officially issued the revised Regulations on the Supervision and Administration of Medical Devices, corresponding with a set of Draft Measures.

• 2021-04-26 02:29:09

Health Sciences Authority (HSA) organized a webinar concerning the ISO 13485 Certification for licensed dealers last March 2, 2021. The information regarding accreditation of certification bodies (CBs) and future ISO 13485 requirement were provided.

• 2021-04-26 02:13:50

Health Sciences Authority (HSA) published “Medical Devices Product Classification Guide” draft comments. This document aims to help the stakeholders in determining whether a product is a medical device or not.

• 2021-04-26 02:04:12

Health Sciences Authority (HSA) introduced a new self – help tool for grouping of medical devices prior to registration. This new tool will aid in the reduction of the number of applications and will in turn reduce the cost and is applicable to different product types.

• 2021-04-20 03:47:45

The major impacts to TFDA's medical device regulations and fees are brought to you by Qualtech.

• 2021-03-22 06:21:15

After seeking for public and specialist opinions for a while. Finally, Thai FDA has announced the official-related announcements regarding a transition from policy-based classification to risk-based classification of medical devices.