• 2022-02-18 08:16:14

Hong Kong's MDD has announced a few changes in the trial schemes on the acceptance of some reference agencies approval. MDD also announced the regularization of the expedited approval scheme for Class II/III/IV General Medical Devices.

• 2022-02-18 08:10:07

Drug-device combination products that mainly function as medical devices (referred to as drug-device combination medical devices in this guideline) are expected to make prevention and treatment of diseases more effective, but may also lead to new technical concerns. Therefore, NMPA formulated two guiding principles to further guide the applicant's preparation for the registration application for drug-device combination medical devices, and to encourage the innovative development of such products.

• 2022-02-18 07:59:52

When there is a threat of public health emergencies, and after the occurrence of public health emergencies, NMPA shall implement emergency review and approval for medical devices required for emergency handling of public health emergencies in accordance with the principles of unified command, early intervention, on-call review, and scientific approval.

• 2022-02-18 07:40:24

Application audit may be conducted during the procedure of inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG). In some applications, audit may be selective under the legislation, however, others may be selected for an audit at the discretion of the delegate. Here we list out the devices that require mandatory auditing under Regulation 5.3. To conclude, a summarised view of the audit process will be provided.

• 2022-01-26 11:18:16

Singapore pioneered the accelerated registration routes in ASEAN in 2018. As the region transitions into the implementation of the ASEAN Medical Device Directive, more countries are opening special access routes and leveraging the review of prior regulatory agencies.

• 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