Home About Qualtech NEWS INDONESIA: e-report and e-post border medical devices and household health supplies workshop – March, 2019
INDONESIA: e-report and e-post border medical devices and household health supplies workshop – March, 2019

April 11, 2019

MOH conducted e-report and e-postborder workshop on medical devices and household health supplies related to the increasing number and types of imported medical devices and PKRT.
Related the workshop, the key point discussed in the workshop has been summarized as follows:
e-report
1. Reporting the distribution of medical device to MOH is mandatory in every 6 months
2. Currently the household product is not necessary to report the distribution.
3. e-report is important for traceability in case adverse event happens.
4. E report can also help MOH identifies if there is any illegal products sold in the market by comparing the data found in the market against the ones in e report. Therefore batch number of the import devices must be recorded in e report.


e-Post Border
1. E-post border is intended for low risk devices.
2. MOH determined some HS code of medical devices which categorized to be inspected post border by issuing Guideline No. 234 year 2018.
3. By transferring the inspection of some medical devices from border to post border, the dwelling time at port may be shortened.
4. MOH will help custom division to review post border clearance through e-postborder where it connects the custom division and ID MOH.
5. Company may register their company to e-Postborder website through: Postborderalkespkrt.kemkes.go.id
6. If there is no importation record in the e-Postborder account, the import may be handled by forwarder (i.e. Customs Services Management Company).
7. Importing devices for exhibition should be reported on e-report. If the device will need to be exported to factory then the it would be considered as “RETUR” in e report.

 

References
e-report and e-postborder workshop on medical devices and household health supplies on March 4, 2019 held by Surveillance Department, Indonesia Ministry of Health

Tags

e-report, e-postborder, Medical Device

 

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Home About Qualtech NEWS INDONESIA: e-report and e-post border medical devices and household health supplies workshop – March, 2019