ASEAN Medical Device Directive (AMDD) – Progress and Updates by AMDC

ASEAN Medical Device Directive (AMDD) was signed by ten member states which include Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.

The ASEAN Medical Device Committee (AMDC) was established with the overall responsibility of coordinating, reviewing and monitoring the implementation of the institutional agreement and shall comprise representatives from the Regulatory Authority of each member state. AMDC scheduled regular meetings twice a year and the recent meeting was held in Bangkok, Thailand in December 2018 while the next meeting will be in the Philippines.  

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2019-01-02T15:54:43+08:00 January 2nd, 2019|Insight, News & Events|

Malaysia : License Transfer in Malaysia

License transfer, usually known as change of ownership, is a common procedure in Malaysia, where the registration certificate of the medical device will be transferred from the existing Authorized Representative (AR) to the new AR

The new AR must hold valid Medical Device Authority (MDA) establishment license, in order to place the medical device in Malaysian market. To conduct the change of ownership of the medical device, the manufacturer must ensure that the existing AR has completed the registration and holds the registration certificate of the medical device (with no pending application in the system).

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2019-01-02T14:58:13+08:00 January 2nd, 2019|Medical Regulation Updates, News & Events|

Indonesia: Brief Report of Medical Device Registration and Household – Health Device Registration in 2018

In relation to the end of year, Ministry Health of Indonesia closes the e-registration system started from 17 November 2018 and will be opened at 14 January 2019.

During 2018, the highest number of medical device licenses issued is on March, numbered 1299 licenses. Whereas the highest number of household-health device licences issuance is numbered 196 licences on January. According to statistical data from Ministry of Health, December is the month with the least number of licenses issued throughout 2018. (more…)

2019-01-02T14:58:55+08:00 January 2nd, 2019|Medical Regulation Updates, News & Events, Uncategorized|