Product Registration in Indonesia

In Indonesia, if you want to expand your business or distribute your product, you have to apply for licenses and product registration

We can help you by explaining the product registration process.


Medical Devices Registration

The improvement of healthcare system in Indonesia, requires more modern medical devices.


Food and Beverage Registration

Indonesian people are open for the new food and beverage, this condition opens wide opportunities for the foreign business player.

 


Food Supplements Registration

Following the trend of healthy life style in Indonesia, the market for food supplement is growing bigger.

 


Cosmetics Registration

The biggest consumer of cosmetic products in Indonesia are the people who lives in big cities.

 

 

To register your products in Indonesia you must have a legal entity in Indonesia and the necessary licenses. If you don’t want to register your company in Indonesia, you need to appoint a local company. Once you decide to appoint someone to register your product in Indonesia, you must be very careful and select your partner properly! Based on Indonesian regulations, you can appoint only one official distributor for your product. That distributor will hold the license for 3 to 5 years, depending upon the product sector. If your partner does not perform well, your market can be closed for several years.

 

In this case, there would be three alternatives how to register imported products in Indonesia as below:

#1 Product Registration under Your Legal Entity in Indonesia; foreign company which already established legal entity in Indonesia may directly register their product under their legal entity in Indonesia. Product registration under own legal entity in Indonesia might be an advantage as they can manage directly the sale of products to some local distributors and register all products under own company and so protect the distribution license of their products in Indonesia. To get to know more about company registration in Indonesia click here.

#2 Product Registrations under Appointed Local Distributors; this option might another alternative if there is no intention to set up legal entity in Indonesia but wish to distribute products in Indonesian market. This local distributor should be selected properly since base on government regulation  there is only one acknowledge official distributor. Moreover, this appointed distributor will be responsible for product registration as well as penetrate local market upon the products and will be the license keeper for 3-5 years. If the appointed local distributor doesn’t perform well then market for this product can be closed for several years.

#3 Product Registrations under proper Third Party; the third options might be work for foreign company that doesn’t have sufficient information about local distributor in Indonesia and also to minimize the risk if the distributor’s performance is out of expectation. This third party can be Consultant Company which already has licenses to register certain product.

 

Product Registration for Several Licenses

Cekindo as the owner of several licenses for importing, distributing and registering products such as medical devices, beauty and health product, food and beverages, etc. can be an example of the third party which can officially act as Indonesian representative. Hence the product registration will be under name of this third party based on the consulting agreement to ensure that the third party does not have any interest to the business. An advantage of register product under third party is that you will have your business in Indonesia under full control and will be flexible to cooperate with more local distributors in same time on Indonesian market.

Product registration in Indonesia is under control of Ministry of Health and independent National Agency of Drug and Food Control (BPOM). For medical devices and household product, it would directly register to Ministry of Health to get the distribution license. While for cosmetic, food supplement, food and beverage, drug and traditional medicine are registered to National Agency of Drug and Food Control.

 

Cekindo Process Flow for Product Registation

#1 Medical Device and Household Product Registration

Medical device registration in Indonesia is one of the most highly regulated in Indonesia. Medical manufacturers and Indonesian medical distributors must to apply for medical product licenses before those devices can be imported, sold, and used in Indonesia (Here you can read about how to register your own local company or how to find a suitable local distributor). Along with household product (HHP) registration, medical device is under authority of the Indonesian Ministry of Health (MOH). 

Medical devices are categorized on risk-based class and this categorization will also influence the period of registration process. Categories of those medical devices are:  class I (low risk, 30 working days), class IIa & IIb (moderate risk, 60 working days), class III (high risk, 90 working days). While the categorization of HHP are class I, class II, and class III.

Medical device and HHP licenses are valid for a maximum of 5 years but can be renewed. However, if there is change on packaging, size or labeling of products, there should be amendment of distribution license. To register a medical device and HHP, a company must have an office or a local distributor in Indonesia registered with the MOH. Applicants can be a:

  • Manufacturer headquartered in Indonesia
  • Local representative or distributor

 

#2 Food and Drug Registration

All food and drug products includes of drug, traditional medicine, cosmetics, food supplement and processed food must fulfill all safety requirements to enter the Indonesian market. This imported food and drug registration is regulated under Indonesian National Agency of Drug and Food Control (BPOM), one of the provisions is the Regulation of the Head of the Agency of Drug and Food Control Republic of Indonesia Number 27 Year 2013 concerning Importation Control of Drug and Food into the Territory of Indonesia.

The registration must be done by the local company, local agent or distributor before the products clear Indonesian customs  (Here you can read about how to register your own local company or how to find a suitable local distributor). Especially for cosmetic registration approval, Indonesia follows the ASEAN Harmonized Cosmetic Regulatory Scheme. For imported food, it is a must to apply for a MLregistration number from the BPOM and the regular registration process takes between 2 to 3 months depending upon the product.

Each registration number will be renewed in every 5 years. While for drug registration follows the standard of ASEAN Common Technical Documents (ACTD) regarding the requirements of drug master file, GMP certificate, clinical studies, stability studies and other additional documents. The drug registration in Indonesia is strictly regulated, can take 1-3 year of registration as Indonesian government mostly consider local manufactured drug instead of imported drug.

 

#3 Trade Marks

Trademark registration in Indonesia is regulated by Trademark Act No. 15 Year 2001Trademark protection is only obtained through registration. Protection based on prior use for unregistered marks is not available. The application process includes a formal examination and an assessment of distinctiveness and similarity with prior trademarks. After passing the examination stage, the trademark is published in the Trademark Official Journal for three months. During the publication process any party can submit a challenge against trademark application.  A registered trademark in Indonesia is valid for 10 years and is renewable./p>

 

Selected clients for Product registration:

  • Product Registration
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  • Local Partner Selection
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  • Local Representation
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  • Local Partner Selection
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  • Local Partner Selection
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  • Local Representation

At Cekindo we register dozens of products every month for our clients and our team is ready to assist you!

 

Feel free to contact us for a free quotation for Product Registration in Indonesia.

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