Last time, We informed that IFETEL of Mexico published the guideline for the use of the IFT Seal for telecommunications or broadcasting products on December 26th 2023. Recently this guideline became effect from June 23th 2024.  Details of the label usage guidelines are as follows: 1.      Things to follow when using IFT Seal 1)      Manufacturers should include the seal in the marking or labelin..

On May 13th 2024, SDPPI of Indonesia announced the new SRD Technical Regulation called “Decree of Minister of Communication and Information of the Republic of Indonesia Number 260 of 2024 (KEPMEN KOMINFO NO 260 TAHUN 2024)”.  This new regulation which offers wider scope compared to the previous SRD regulation will take into effect 90 days after the stipulated date, on August 11th 2024. Following..

Recently, We had informed you of public consultation of “Amending section 2 of memorandum circular No.03-05-2007”, the newly proposed circular. On 5th July, 2024, NTC of Philippines have issued the announcement regarding to this circular which is about the opening of the WIFI 6E. This circular will be effective on 20th July.    Accordingly, 5925-6425MHz frequency band was added for RLAN and HIPE..

Singapore HSA(Health Sciences Authority) applies Review Fee Increase Effective July 1, 2024. With effect from 1 July 2024, a fee increase averaging 5% will be implemented, with a minimum increase of $1 and capped at $200 per fee item. The increased medical device fees are briefly as follows.1.     Medical Device RegistrationProduct registration and evaluation feeClass BClass CClass DClass D with..

Thailand's Food and Drug Administration (TFDA) has issued guidelines on May 9, 2024 for registration of software (SaMD) to determine whether SaMD software is suitable as a medical device. The guidelines for Software as a Medical Device (SaMD) registration are briefly as follows.  Type of medical device software >-       Embedded Software: Software embedded in medical devices-       Standalone So..

On May 27, 2024, the Ministry of Food and Drug Safety (MFDS) posted a revised version of the "Medical Device Adverse Event Report Guidelines" reflecting the revision of the standard code for medical device abnormalities and the frequently used standard code case. The medical device safety information management system is briefly as follows.1. If the medical device handler recognizes that death o..

HAS Medical device product registration applications,  specifically for in vitro diagnostic devices, should be submitted online through MEDICS, utilizing the CSDT or IMDRF IVD MA ToC.In this regard, the Singapore HSA(Health Sciences Authority) issued a directive document on the submission of product registration on March 1, 2024.It details the process for uploading documents related to either th..

On May 16, 2024, the Indonesia Ministry of Health issued an Announcement Number FR.03.01/E/884/2024 about the Implementation of the CDAKB Certificate (Good Distribution Practice of Medical Devices) as a Requirement for Marketing Authorization. The Ministry of Health (MoH) is providing a transition period from May 1st to June 30th, 2024. Therefore, Local Distributors and License Holders must have..

Philippine FDA announced FDA Circular No.2024-003 on March 26, 2024. This issuance extended the dates for the application of a CMDN and CMDR for all Class B, C and D medical device that are not included in the list of registrable medical devices based on FC No. 2020-001-A. All Class B, C and D medical devices that are not included in the list of registrable medical devices based on FC No. 2020-0..

On February 22, 2023, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) (the COVID-19 Medical Devices Regulations) came into force and created a permanent regulatory framework under Part 1.1 of the MDR for COVID-19 medical devices. Health Canada has expanded the scope of Part 1.1 f..