The Center for Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (Philippines) have announced that they will be conducting an inventory and processing of the pending applications for registration of medical devices. In line with this, FDA Philippines has declared an application holiday for CMDN
On December 14th, 2023, the Medical Device Authority (MDA) of Malaysia issued a requirement for surveillance report on implantable medical devices on the homepage of Medcast 2.0+ system. This requirement applies to distributors in which as per clause 27.(1) until 27.(3) in GDPMD, establishments that distribute implantable medical devices shall
On December 12th, 2023, the MDA issued 2 (two) guidance documents as follows: MDA/GD/0062 Harmonised Classification of Medical Devices in ASEAN, Second Edition. MDA/GD/0063 Harmonised Borderline Products in ASEAN, Second Edition. These are the highlights of each regulation: Harmonised Classification of Medical Devices in ASEAN 2nd Edition (MDA/GD/0062) Harmonised Borderline
On 5 December 2023, the General Director of Pharmaceuticals and Medical Devices of the Ministry of Health (MoH) of Indonesia released a circulation letter No: HK.02.02/E/2379/2023 regarding the List of SNI ISO/IEC 17025:2017 Accredited Testing Laboratories for Medical Devices and Household Supplies. SNI itself is an abbreviation of Standar Nasional
On 5 December 2023, the Ministry of Health (MoH) of Indonesia released an announcement letter No: FR.03.01/E.V/2510/2023 regarding the maintenance process of the MoH platform for online licensing system of medical devices and household supplies registration, issuance of online certificates, and issuance of medical devices distribution license (IDAK). Therefore, the
Based on Law No. 33 of 2014 regarding Halal Product Guarantee, all foreign halal products imported into Indonesia do not require to apply for a local halal certificate, if the foreign halal certificate is issued by a foreign halal institution that has collaborated on mutual recognition of halal certificates with
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