• 2022-01-26 10:47:58

Recently, HSA has finalized the "Medical Devices Product Classification Guide" after concluding the discussion with stakeholders. This document aims to help the stakeholders in determining whether a product is a medical device or not.

• 2022-01-26 10:39:04

Malaysia's Medical Device Authority (MDA) has published the Fourth Edition of its Guidance Document on Medical Device Labelling Requirements. This guidance document is beneficial in informing stakeholders about the additional requirements and materials that must be included in medical device labelling marketed in Malaysia.

• 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.

• 2022-01-26 08:15:53

TGA has already implemented reforms to the regulation of software-based medical devices from 25 February 2021. Under the new regulation, some software may be excluded from the TGA regulations, or although still regulated by TGA they may be exempted from the need to include the product in the ARTG. In the following, we gathered some FAQs and have summarised TGA’s article to help you have an insight on what is required to operate legally in Australia.

• 2021-12-27 06:18:36

PFDA announced that abridged route for processing of Registration and Notification Applications for Medical Devices will commence starting Nov 25. This aims to increase the efficiency of public access to safe, quality, and effective medical devices

• 2021-12-27 05:12:19

MDD announced the closing of the ongoing trial scheme for expedited approval of Class II/III/IV General Medical Device Listing Application on 31 December 2021. The limit application for applicants who wish to apply through the trial scheme have been lifted.

• 2021-12-27 04:54:37

NMPA has issued a new regulation of the “Management Provision on the Self-Testing for Medical Device Registration” which include the requirements for manufacturer’s capacity for self-testing, quality management system, self-testing report and related responsibilities.

• 2021-12-27 02:04:41

TGA regulates all medical devices that are for introduction into the body as Class IIa (low-medium risk) or Class IIb (medium-high risk) devices. Transitional arrangements are in place to ensure that manufacturers can continue to supply their previously registered devices while they apply for them to be included in the ARTG in accordance with the new classification.

• 2021-12-27 01:30:53

TGA has introduced a new definition for custom-made medical devices. The impact of the new definition is the majority of devices previously supplied under the exemption for custom-made medical devices no longer meet the definition of a custom-made medical device and will need to be included in the Australian Register of Therapeutic Goods (ARTG) if they are being supplied in volumes of more than five per financial year.

• 2021-11-24 10:36:48

2020 and 2021 had some regulations newly introduced by various ASEAN regulatory agencies. When these come into full implementation in 2022, stakeholders need to be well-equipped to face them and prepare a contingency plan to adopt them for the medical devices already in the market. In this article, we shall take a look at the regulations to be fully implemented starting 2022 in Malaysia, Singapore, Indonesia, Thailand, Vietnam and Philippines.