In Vitro Diagnostics: HIV Test Kit Registration in Indonesia

HIV

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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2018-10-24T14:40:43+08:00 May 29th, 2018|News & Events|

HSA: Faster Access to the Singapore Market for Low-Risk Medical Devices

SS 620:2016

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…)

2018-10-24T14:41:15+08:00 May 29th, 2018|News & Events|

National Telecommunications Commission (NTC) Rules and Regulations for Medical Devices with Wireless Data Networks

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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2018-10-24T14:42:00+08:00 May 29th, 2018|News & Events|

Thailand: Guidance for Eye Products – Identification and Classification

eye products

The Thailand Food and Drug Administration (FDA) recently published guidance for the identification and classification of eye products. Find out which products are classified as non-medical devices, medical devices, medicines or cosmetics.

In March 2018, the Thailand Food and Drug Administration (FDA)  published guidance to support importers, manufacturers, and exporters in the identification and classification of eye products. The following eye products are classified as medical devices:

  • Glasses frames with power lenses
  • Sunglasses with power lenses
  • Finished spectacle lens with power
  • Lubricating/rewetting drops for contact lens
  • Ophthalmic Viscosurgical Device (OVD)
  • Keratome blade
  • Lensmeter
  • Color blindness tests
  • Snellen chart
  • Amsler grid
  • Laser safety eyewear, laser safety glasses, laser safety goggles
  • Eyelid compression device

Find out more here: Guidance in Thai or  Guidance in English

2018-06-01T16:17:12+08:00 May 29th, 2018|News & Events|