The FDA published a revised MDSAP AUDIT APPROACH (MDSAP AU P0002.009) on August 6, 2024.The revision from MDSAP AU P0002.008 to 009 is briefly as follows. 1. Australia (TGA)As a result of changes to the Guidance for Australia (TGA) country-specific requirements, the following items have been revised or removed from the TGA requirements.1) Management - Task 5 & Task 82) Device Marketing Authoriza..

The National Medical Products Administration (NMPA) of China issued the Regulations on July 8, 2024 to steadily promote the relevant work of high-frequency treatment devices and high-frequency skin treatment devices, and take into account the requirements of public equipment safety and orderly development of the industry. Annex 09-07-02 of the “Notice on Partial Adjustment of the Medical Device ..

The Australian Therapeutic Goods Administration (TGA) has updated its medical device distribution record requirements from 23 May 2024. Under section 41FO of the Treatment Supplies Act 1989, sponsors of medical devices supplied and exported from Australia must keep the following distribution record.Expedite any recalls of the medical devices.Identify the manufacturer of each batch of devices.Rec..

In Australia, sunscreen is classified as a primary sunscreen or a secondary sunscreen depending on the SPF index. If it is classified as a medical product according to the performance of sunscreen, it is subject to TGA regulation, and if it is classified as a cosmetic, it is subject to AICIS regulation. Australia's Therapeutic Goods Administration (TGA) has announced updated requirements for sun..

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..