Home About Qualtech NEWS INDONESIA: Design for Labelling Packaging of Marketing Authorization of Medical Devices and Household Health Supplies – March, 2019
INDONESIA: Design for Labelling Packaging of Marketing Authorization of Medical Devices and Household Health Supplies – March, 2019

March 12, 2019

Regarding the implementation of the Digital Signature system which began on 14 February 2019, the Indonesian Ministry of Health determines the format of Labelling Material Design documents uploaded for product registration as follows:

a. The paper size should be A4.

b. The labelling material design should be provided in colour.

c. The maximum PDF version used is 1.4.

d. The information of distributor name and address as well as registration number added into the labelling cannot be stamped onto the pdf file but it must be affixed in the pdf therefore it cannot be edited.

The applicant is expected to pay attention to the format; nonconformity may result in the labelling not completely attached to the registration certificate or some parts cannot be printed or no QR Code included.

In connection with the implementation of the Halal Product Assurance Law, MOH ask applicants to record Medical Devices derived from and / or containing animal materials. The data format can be accessed via the following link: Informasi Alat Kesehatan  

 

Reference:

http://regalkes.depkes.go.id/index.php#home/berita/1000543 

http://regalkes.depkes.go.id/index.php/home/fileDownload/BERITA_FILE.pdf/1000538 

http://regalkes.depkes.go.id/index.php#home/berita/1000554

 

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Home About Qualtech NEWS INDONESIA: Design for Labelling Packaging of Marketing Authorization of Medical Devices and Household Health Supplies – March, 2019