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.
Imported Household Product Registration Categories
Household product in Indonesia is categorized in 3 classes based on its risk level as below:
- Class I (low risk)
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.
- Class II (medium risk)
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.
- Class III (high risk)
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.
The Criteria
For possessing the marketing license, the company should follow criteria as below:
- Safety and Efficacy of HHP are proven by using non prohibited materials and not exceeding the determined content limit in accordance with the regulation and/or clinical data or other data that are needed.
- Quality, based on company good manufacturing practice and using materials with appropriate specification and complies with the determined requirements shown by the production certificate.
1. Who is allowed to obtain the marketing license?
- HHP importer which already have appointment from the company or business representative that has the power as sole agent by indicating the type of product of agent and acknowledged by the local representative of the Indonesia with term of appointment minimum 2 years.
- Non sole agent but have power attorney to register the HHP from the HHP production company or from the responsible company overseas.
- Company which have production certificate to carry out the reassembling/repacking of imported products.
2. How to Obtain Marketing License (Izin Edar)?
Process of obtaining the marketing license would be divided into 2 steps:
- Step of determining the class of household product; this step consist of class verification process and payment for non-tax state revenue (PNBP) which will take approximately 17 working days.
- Evaluation process; consists of evaluation and verification of safety requirements, efficacy and quality. After going through evaluation process, there may be 3 results such as approval for marketing license, notification for required additional data or rejection letter.
3. What Documents Should be Prepared?
Required documents for registering imported HHP as below:
- Filled application form
- Letter of Appointment
- Certificate of Free Sale (CFS)
- Certificate of ISO 9001
- Business License and tax ID
- Statement letter of willingness to trasnfer distributor rights if there is another more eligible distributor
- Statement letter of willingnes to meet safety requirements
- Detail ingredients and production process
- Specification of raw materials and packaging
- Specification of stability studies
- Using instruction
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.
