• 2021-06-04 09:34:53

In this webinar, you will learn more about Brexit and how Geopolitics affects medical device regulations. Our expert will introduce you to UKCA. Moreover, Ms. Fatehi will discuss the transitioning out period and will outline how the future for the U.K. market will look like.

• 2021-05-22 07:03:29

As TFDA's Medical Device Act has come into force on May 1st, 2021, supporting measures and announcements following the Act have sprung up like mushrooms recently. This article provides a quick guide and introduction to each corresponding measure.

• 2021-05-22 06:49:37

Recently, NMPA issued a Notice on Registration of Medical Device Technical Dossier (No. 36 of 2021), which will facilitate medical device manufacturers to choose raw materials and key components, simplify registration declaration, improve the quality of medical device review and approval, establish a more scientific and efficient review and approval system, and encourage innovation.

• 2021-05-22 05:31:34

The Indonesian Ministry of Health has issued guidance on reporting of Adverse Events (in Indonesia: Kejadian Tidak Diinginkan/ KTD). The guidance book explains the types of adverse events (KTD) that must be reported to the Ministry of Health and the reporting period.

• 2021-05-22 05:17:57

In April 2021, Medical Device Authority (MDA) published new guidelines for the implementation of a medical device regulator system which is listed the requirements for application for medical device advertisement approval. The guidelines are to helps the establishment to comply with the regulations Act 737. These guidelines shall be read together with Guidance Documents of Code of Advertisement (COA).

• 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.