September 2024

Regulatory Affairs Update: Indonesia

Indonesia: New Draft of Minister of Health Regulation concerning Health Supplies

This new draft is a derivative of the Presidential Regulation No. 28 Year 2024 and contains 282 articles which regulates the health supplies. It defines that Health Supplies are all materials and equipment necessary for Health Efforts such as Pharmaceutical Preparations, Medical Devices, and other Health Supplies according to the needs. The scope of this

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Regulatory Affairs Update: Indonesia

Indonesia: Update on the List of Overseas Testing Centres for Certification Purposes of Telecommunication Devices and Equipment

Last April 25, 2024, the Indonesia Ministry of Communication updated the list of the laboratories/testing centers indicated in Decree No. 109 of 2024. This decree refers to the Determination of an Overseas Testing Centre for Certification Purposes of Telecommunication Devices and/or Equipment issued by the Director General of Resources Management and Equipment of Posts and

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Regulatory Affairs Update: Indonesia

Indonesia: GDPMD Certificate as Mandatory Requirement for e-Catalogue Listing

The General Director of Pharmacy and Medical Devices signed a circular letter No. HK.02.02/E/1753/2024 on 09 September 2024, regarding the implementation of the Good Distribution Practice of Medical Device (GDPMD) Certificate as a mandatory requirement for listing in the e-Catalogue system. The circular letter highlights the following information: 1. Every medical device distributor is required

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Regulatory Affairs Update: Indonesia

Indonesia: New Decree concerning the Technical Standards of Short-Range Devices

The Minister of Communications and Informatics signed a New Decree Number 260 of 2024 concerning the Technical Standards of Short-Range Devices (SRD) on 13 May 2024. The regulated SRDs are as follows: 1. Bluetooth IEEE 802.15.12. Near Fields Communications (NFC)3. Radio frequency Identification (RFID)4. Ultra-wide bands (UWB)5. Low-Rate Wireless Personal Area Network IEEE 802.15.46. Cordless

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Andaman Medical: A Partner in Global Diagnostics Company’s Expansion into Malaysia

Fibronostics Fibronostics is a global diagnostics company shaping the future of non-invasive diagnostics. The company provides advanced solutions for the screening, identification, and monitoring of major metabolic diseases, which impact large patient populations globally. Fibronostics is a global company founded in Singapore, with labs and operations in the US, focusing on delivering innovative diagnostic tools

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