Regulatory Updates

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

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

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

Regulatory Affairs Update: Indonesia

Indonesia: Issuance of Regulation governing the Certification of Telecommunication Devices and/or Telecommunication Equipment

The Minister of Communications and Informatics in Indonesia issued regulation No. 3 of 2024 concerning Telecommunication Device and/or Telecommunication Equipment Certification. This regulation consists of 62 articles that describe and regulate the requirements applied in the certification process of telecommunication devices and/or equipment. As stated, any telecommunication device and/or equipment

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