Imported household product registration in Indonesia is regulated under Regulation of the Minister of Health of the Republic of Indonesia Number 1190/Menkes/Per/VIII/2010 regarding Medical Devices and Household Products Marketing License. Based on this regulation, household product (HHP) includes the equipment, materials, or mixture of material for the maintenance and treatment of human health, control of pet fleas, household and locations.
Household product in Indonesia is categorized in 3 classes based on its risk level as below:
This class includes household product which not cause any serious effect such as irritation, corrosive and carcinogenic. Household products under class I e.g. cotton and tissue. The evaluation process would take about 45 working days exclude period for determining the class.
Includes household product which cause irritation, corrosive but doesn’t cause serious effect like carcinogenic. Before distributing, the product should be registered by enclosing the result of laboratory test and will take approximately 80 working days. Products which are categorized under class II such as detergent and alcohol.
This class includes household product which contains pesticides such as repellent and it can cause serious effect like carcinogenic. Along with registration, applicant should enclosed result of laboratory test and should already acquire confirmation from Pesticide Commission under Ministry of Agriculture. The registration will take about 100 working days.
However, to be able register HHP in another mean to obtain the marketing license (izin edar), firstly manufacturer or appointed distributor should have HHP distributor license (izin penyalur PKRT). Marketing license is the license for company which will become the importer as well as distributor for this HHP within the territory of Indonesia based on the evaluation on the quality, safety and efficacy from evaluation team and expert team.
For possessing the marketing license, the company should follow criteria as below:
Process of obtaining the marketing license would be divided into 2 steps:
Required documents for registering imported HHP as below:
Besides required documents above, importer/distributor should have concern on labelling of HHP. Labelling might be in the form of pictures, colors, writing which affixed on the package. The labelling at least contains information of product name/trade name, name and address of manufacturer or importer, active ingredients and concentration of HHP product, instruction of use, warning in Indonesian language, expiration date, batch number, production code.