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..

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..

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..

What is NOM (Norma Oficial Mexicana)? Mexico regulatory standards that manufacturers meet to protect the safety of medical device, IVD, and pharmaceutical users. Mexico COFEPRIS invalidated the standard NOM-137-SSA1-2008 on medical device labeling published in December 2008, and announced an updated new NOM for medical device labeling, NOM-137-SSA1-2024, on April 23, 2024. Updated NOM-137-SSA1-2..

食品医薬品安全処で物理·化学的特性分析資料に関する資料の要件、評価原理および過程などを説明し、医療機器の生物学的評価資料準備に役立てようと「医療機器の生物学的安全性評価のための非吸収性高分子材質の物理·化学的特性評価ガイドライン」を2024年04月08日に発刊しました。 市販前のサイバーセキュリティ指針のアップデート草案の内容は、簡単に以下の通りです。 非吸収性高分子材質の物理·化学的特性評価ガイドラインの内容は簡単に以下の通りです。 1. 適用範囲ISO 10993-1:2018に基づき、人体と非接触医療機器を除くすべてのタイプの非吸収性高分子材質医療機器(直接及び間接接触医療機器)に対して適用 2. 医療機器の物理·化学的分析及び評価l   概要: 物理·化学的分析資料はISO 10993-17の毒性学的危険事情(Toxicological risk assessment)及び追加..