Monthly Archives: May 2018

In Indonesia, an HIV disease test kit has to be tested locally before the product can be submitted for registration with the Ministry. The local clinical test must be conducted by the clinical pathology laboratory of the national government hospital.

Like other medical devices, in vitro diagnostic devices (IVDs), such as HIV test kits, are highly regulated by the Ministry of Health of Indonesia. The registration documents for in vitro diagnostic devices are similar to those required for medical devices, with some additional mandatory requirements:

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The Health Sciences Authority (HSA) Singapore updated its regulatory legislation to facilitate faster access for certain lower-risk medical devices and standalone mobile applications. The changes will take effect from 1 June 2018.

The Health Science Authority (HSA) Singapore has recently announced that its regulatory legislation will be enhanced to facilitate faster access for certain lower-risk medical devices and standalone mobile applications. The changes will take effect from 1 June 2018.  (more…)

The National Telecommunications Commission of the Philippines issues permits and certificates to importers of indoor equipment and devices that require Wireless Data Networks (WDN) or are WIFI-enabled/Bluetooth medical devices.

Background
The National Telecommunications Commission (NTC) is responsible for the supervision, adjudication, and control of all telecommunication services in the Philippines. The NTC works closely with the Department of Science & Technology, Advanced Simulation Technology Inc., and the Department of Information Science & Telecommunication.

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