• 2022-02-18 08:51:05

Health Sciences Authority (HSA) addresses issues about the creation of new Product Owners (PO) by applicants even though there is an existing one. HSA shares the steps in changing the PO ID number via Change Notification. HSA reminds applicants to search first for the existing PO ID before creating a new one.

• 2022-02-18 08:32:17

PFDA released draft document of the updated guidelines for in-vitro diagnostic medical devices (IVD) certification. This new regulation will conform to the risk-based classification of the ASEAN medical device directive (AMDD). A tentative list of registrable IVDs together with a revised set of requirements to register COVID-19 Test Kits was also released on a separate document.

• 2022-02-18 08:27:38

The Medical Devices Authority (MDA) announced the notification prohibiting the sale of optical devices and contact lenses on any e-marketing platform except registered optometrists, opticians, and businesses registered with SSM, following standards published on the Malaysian Optical Council (MOC) official website.

• 2022-02-18 08:22:55

Indonesia MoH has officially implemented a notification scheme for certain class A medical devices in the REGALKES system since 10th January 2022.

• 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 10:55:53

The Health Sciences Authority (HSA) has published an update on the Regulatory Fees for Health Products. This is to ensure that the evaluated products meet the required standards of quality safety and efficacy. It is also necessary to recover part of the costs for the services rendered to businesses.