Indonesia MOH Go Digital to help Industry with Online Medical Device Classification / HS code, Digit


Online Medical Device Classification Guideline

MOH Indonesia provides online classification guideline to help applicant to define the risk classification of the medical device, the device category and its subcategory, product type and HS code.

Digital Signature

MOH Indonesia informed that for the Digital Signature system in the Directorate of Assessment of Medical Devices and PKRT, the related Design Label files should be uploaded according to the specified format, namely:

  • Using A4 size;

  • Color packaging design marking;

  • Using PDF version 1.4;

  • Inclusion of distributor information and registration number must be done before pdf, it cannot be digitally edited/pasted via software.

If the Certificate is still found with error for those issued from 14 January 2019 such as inappropriate labeling information or not being attached, with cut off or without QR Code, please immediately inform MOH via email to penalkes806@gmail.com.

Reference: http://regalkes.depkes.go.id/index.php/home/fileDownload/BERITA_FILE.pdf/1000543

Halal Product Guarantee Law

In connection with the implementation of the Halal Product Guarantee Law, the Authority request company on the data collection for medical devices originating from and / or contain animal elements (made from animal raw materials).

Source: MOH Indonesia

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