On January 1, 2025, the Ministry of Health (MoH) of Vietnam announced the issuance of 04/2025/ND/CP, which includes amendments and supplements to 98/2021/ND-CP regarding medical device management, as well as updates to 07/2023/ND-CP.  The updated content is as follows: 1. Extended Validity of Import Licenses. a) Import permits for medical equipment issued between January 1, 2018, and December 31..

On December 16, 2024, the Indonesian Ministry of Health (MoH) issued a regulation (FR.03.01/E.V/2672/2024) classifying Dried Blood Spot (DBS) products as medical devices.  This regulation refers to the classification of DBS as a medical device under the U.S. FDA’s CFR 21 and follows Law No. 17 of 2023 on Health, Article 143, which mandates that the supply of pharmaceuticals, medical devices, and..

On October 30, 2024, the Ministry of Health (MoH) of Indonesia introduced new requirements for the Medical Device Distributor License (IDAK). The aim of these changes is to improve standards within medical device companies and ensure accountability, in accordance with Ministerial Regulation No, 14/2021 on risk-based product licensing in the health sector.  The new requirements for the Medical De..

On August 16, 2024, Vietnam introduced new guidance allowing the update of specific documents related to medical device registration facilities on the IMDA website during the regulatory review process.  This guidance permits updates for two types of documents related to changes in registration facilities. 1. Updating documents related to changes in registration facility information      - When c..

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..

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..

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..

Indonesia is the third country to implement the AMDD standard, following Singapore and Malaysia. Indonesia is classified into Class A, Class B, Class C, and Class D according to risk, and product groups are broadly classified into five categories. · Radiation electromedical devices · Non-radiation electromedical devices · Sterile non-electromedical devices · Non-sterile non-electromedical device..

Um die medizinische Geräte in Indien zu verkaufen, müssen diese Geräte bei MoH registriert werden. MoH Ministry of Health - Das indonesische Gesundheitsministerium übernimmt die meisten Aufgaben im Zusammenhang mit der Regulierung von medizinischen Geräten, wie z. B. der Registrierung und Nachbehandlung von diesen Geräten und GMP. - Um die Registrierung der medizinischen Geräte durchzuführen, mu..

Die vietnamische MoH (Ministry of Health) veröffentliche am 31.12.2020 einen Durchführungsbeschluss für die Einreichung von Annual Inspection und Technical Capability Assessments für bestimmte medizinische Geräte-Listen. Circular No. 30/2020 Die Geräte, die von o.g. Einreichung beeinflusst werden, sind nämlich : Ventilators Anesthesia Machines Electrical Surgical Units (ESU) Infant Incubators De..