As of October 11, 2024, the Ministry of Food and Drug Safety has registered the revised version of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials). The revised contents of the Guidelines for Handling Safety Information, such as Side Effects of Medical Devices (Guidelines for Public Offi-cials) are briefly as follows. 1. R..

Vietnam's Ministry of Health announced on August 30, 2024 regarding the domain change of the online public service system for medical device management. Vietnam's Ministry of Health changes the domain of the online public service system for medical device management as follows. - Domain before change (DMEC): https://dmec.moh.gov.vn- Domain after change (IMDA): https://imda.moh.gov.vn From Septem..

Thailand's Ministry of Health issued a notice affecting medical device manufacturing and marketing authorization on June 20, 2024, and the contents are as follows. 1.     Manufacturing ControllersAll establishments, license holders, or notified entities must appoint at least one manufacturing controller with the following qualifications and duties Qualifications and Duties >- A bachelor’s degree..

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..

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..

The U.S. Food and Drug Administration published a draft guidance document on March 13, 2024, of Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act. FDA intends to incorporate the updates proposed in this draft guidance into the Premarket Cybersecurity Guidance as one final guidance document after obtaining and considering public comment on these proposed select..

With the implementation of the revised Medical Device Management Enforcement Decree (98/2021/ND-CP) in 2021, Vietnam (MoH) extended the registration expiration date for Class C and D medical devices by one year to December 31, 2022, and made distribution registration mandatory from 2022. However, during that period, companies experienced a lot of inconvenience and confusion as the Ministry of He..