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The U.S. Food and Drug Administration published a draft guidance document on March 13, 2024, of Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act. FDA intends to incorporate the updates proposed in this draft guidance into the Premarket Cybersecurity Guidance as one final guidance document after obtaining and considering public comment on these proposed select..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

The Hong Kong Medical Device Division (MDD) has announced that the “Essential Principles of Medical Device Safety and Performance” (Technical Reference: TR-004) will be available for use in the Medical Device Administrative Control System (MDACS) from 1 January 2024. Hong Kong's existing reference countries were Australia, Canada, the European Union, Japan, and the United States, but as the info..

MDSAP is a certification system created by five regular member countries, the United States, Japan, Canada, Australia, and Brazil, for the purpose of joint review according to international standards for medical device safety and quality control. From December 19, 2023, the Ministry of Food and Drug Safety revised part of the Medical Device Manufacturing and Quality Control Standards to improve ..

In order to receive MFDS ClassII certification, technical document review by technical document review agency is essential. Currently, the fee for reviewing technical documents for second-class medical devices has been frozen for 13 years, resulting in a vicious cycle of worsening management of review institution, delayed complaint processing periods, and deterioration of civil service. To refle..