A Production Certificate is a primary requirement for manufacturing Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies (PKRT). According to the Indonesian
There are 16 categories of medical devices and in vitro diagnostic medical devices that are limited based on their function and application in the health
Symbol Description ManufacturerThis Medical Device Symbols must be displayed alongside the name and address of the manufacturer, positioned next to the symbol Authorized representative in
The supervision of advertisements for medical devices and household health supplies (PKRT) circulating in the community must be conducted in accordance with the applicable marketing
Medical devices have risks ranging from low risk to high risk that can potentially cause serious injury, to permanent disability and even death. Therefore, medical
Medical devices that do not meet standards and/or requirements may be subject to sanctions in the form of an order to withdraw from circulation and
The Certificate of Good Medical Device Distribution Practices (CDAKB) is important to prevent the entry of substandard and counterfeit medical devices into the medical device
The branch of a health equipment distributor is a business unit of a Health Equipment Distributor that has obtained a Certificate of Good Distribution Practice
Important Changes and Compliance Requirements for Medical Device Distributors In accordance with Government Regulation Number 5 of 2021 regarding the Implementation of Risk-Based Business Licensing
In Indonesia, the distribution of medical devices is crucial for ensuring the accessibility and availability of healthcare equipment across the archipelago. IDAK, which stands for
Wisma PMI 6th Floor Jl. Wijaya I No.63, RT.8/RW.1, Petogogan, Kec. Kby. Baru, Kota Jakarta Selatan, Daerah Khusus Ibukota Jakarta 12160
marketing@insightof.co.id
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