Indonesia Ministry of Health explained about the multiple authorizations of the same product originated from the same Principal or Manufacturer to the several Medical Device Distributor (abbreviation in Indonesia: PAK) in Indonesia and in this article will be named as “Double Agent”. This explanation is intended to give more knowledge to Distributor in Indonesia on the definition of “Double Agent” itself and also the step needs to be taken by the PAK prior doing cooperation with Manufacturer or Principal, and vice versa.
The regulation related to the “Double Agent” is written on Minister of Health Regulation No. 62 of 2017, Article 13 which stated, “Each type of Imported Medical Devices, In Vitro Diagnostic Medical Devices and PKRT under 1 (one) trade name/brand name originating from Manufacturer or Principal is authorized only by 1 (one) PAK or 1 (one) Importer of PKRT”. Referring to this Article, it means that 2 different PAKs can’t be authorized for the products with the same brand name/trade name that falls under the same product category originated from the same Manufacturer or Principal.
Ministry of Health give the step that can be followed by PAK prior doing product registration. By doing this, PAK can understand whether the same product has been authorized by other PAKs or not. The steps are as follow:
- 1. Go to infoalkes.kemkes.go.id, click on “Produk” and choose an option “Luar Negeri (Impor)”.
The next step is to select "Produsen" / manufacturer and type the manufacturer’s name on the search column.