Indonesia: Guidelines on MD/IVD registration evaluation, Grouping, LOA, No Double Agent

MOH Indonesia published Guidelines on the evaluation requirements on each document for Indonesia Medical device and IVD registration.


Refer to “Guidelines For Evaluation Of Medical Devices and In Vitro Diagnostic Medical Device According To The Regulation of Minister Of Health Of The Republic Of Indonesia Number 62 Of 2017”

Technical requirements also available on the following topics related to Grouping, LOA (Letter of Authorisation of Indonesia Agent) and No Double Agent/Product license holder.


-Grouping: Single, Family, System, Test kit IVD, System IVD, Group


Refer to “Guidelines for Grouping Medical Devices and In Vitro Diagnostic Tools”


-LOA: Can be either given by Manufacturing site (A), Product Owner (given by A to Product owner or given by A via Distribution Centre) or Distributor (given by A for Product owner via Distribution Centre)


-Product license holder: No Double Agent allowed for product with same Manufacturer name/address, same product type, same brand.


Refer to “Technical Requirements”
























Please contact ARQon team should the company require understanding or strategy of submission of different medical device/IVD grouping, LOA options and Product license holder for multiple sub-distributors in Indonesia.


Source:

1. Guidelines For Evaluation Of Medical Devices and In Vitro Diagnostic Medical Device According To The Regulation of Minister Of Health Of The Republic Of Indonesia Number 62 Of 2017

2. Guidelines for Grouping Medical Devices and In Vitro Diagnostic Tools

3. Technical Requirements


Contact us at: info@arqon.com



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