Indonesia: Risk Class Determination In The Permit Registration For Medical Devices

As of October 2018, it is mandatory for a registrant to independently determine the risk class of a medical device in order to register for a Distribution Permit in Indonesia.

According to the Ministry of Health regulation no. 62/2017 regarding general medical devices, in vitro diagnostic medical devices, and household-health devices, the process of determining the risk class of a device and generating the appropriate billing code will be performed independently by the registrant from Monday, 22 October 2018. 

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2018-11-07T09:21:10+08:00 November 1st, 2018|News & Events|

Singapore: Moderate Fee Increase For Medical Device Registrations

The Health Sciences Authority (HSA) Singapore has revised its fee structure. A moderate increase in medical device registration costs will be implemented from 2019. 

In August, the Health Science Authority (HSA) in Singapore announced a moderate increase in its fee structure to cover rising operational costs. The HSA reviews and regulates health products in Singapore to ensure quality, safety and efficacy. This is the first time in a decade that the agency has decided to impose an increase in its fees for its services. The changes will be implemented from 2 April 2019 with increases ranging from $1 to $200 depending upon the service.  

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2018-11-02T10:18:59+08:00 November 1st, 2018|News & Events|

Canada Delegation and RAPS Convergence

The Andaman Medical Vietnam team had a chance to join the Vietnam Healthcare Business Delegation in Canada from the 22 September 2018 to 01 October 2018 and attended the RAPS Regulatory Convergence from 01 October to 4 October 2018.

We had two great opportunities to connect with local manufacturers in the three biggest provinces of Canada: Ontario, Quebec and British Columbia. The Healthcare Business Delegation serves as a bridge for Vietnamese and Canadian companies to collaborate in one of the most dynamic Southeast Asian markets. 

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2018-11-01T06:42:37+08:00 November 1st, 2018|News & Events|