• 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.

• 2021-09-29 00:33:56

HSA recently issued updates to some pre-market registration-related guidance documents and technical reference documents. Specifically, the GN-15, GN-17, GN-18, TR-01, and TR-02 were updated. The changes mainly deal with the addition of cybersecurity requirements for medical devices. This is a very important update since it is imperative to protect devices that are used in the healthcare industry from hackers and other cyberthreats.

• 2021-08-02 04:41:50

HSA has recently released the “Guidance on the Medical Device Unique Device Identification (UDI) System”. From 2022 in transitioning phases, HSA requires medical devices to be marketed in Singapore to be equipped with UDI-DI.

• 2021-08-26 12:58:20

In July, MOH released two Official Dispatches as guidance on registration routes and document preparation to import SARS-CoV-2 IVD medical devices and biologicals, especially SASR-CoV-2 Antigen Rapid Test Kit (RTK).

• 2021-08-02 04:25:55

Back in December 2020, MDA had published a new guidance document on grouping in-vitro diagnostic medical devices. This guidance is an extension of the MDA/GD/0005 Guidance Document of Product Grouping focused on IVD devices.

• 2021-08-01 16:05:20

The Indonesian Ministry of Health has issued new guidance on Withdrawal and Destruction of Non- Conformity Medical Devices. It describes the types, criteria, roles and responsibilities, classifications, and procedures for withdrawing medical devices from circulation. It is hoped to assist manufacturers, importers, and distributors in better managing post-market activities such as the withdrawal of medical devices in Indonesia.

• 2021-06-25 12:51:04

The guidance, released as Decision No. 2426/QĐ-BYT, was constructed according to AMDD and with reference to the guidance of Singapore and Malaysia, and applicable to medical devices Class B, C, D including in-vitro diagnostic IVD MD.

• 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 05:25:28

Medical Device Authority (MDA) published a second edition guidance document of Code of Advertisement (COA). The COA promotes the establishment of the standards for the ethical advertising of medical devices in Malaysia. COA also specifies the requirement for which situation requires approval or not from MDA.

• 2021-05-22 04:20:30

PFDA shared the updated procedure for the issuance of special certification for COVID-19 test kits following recent guidance for minimum performance requirements of different types of COVID-19 Test Kits.