Entry Market in Indonesia

Product Registration

cekindo.com

Since 2012

Product Registration in Indonesia If you want to expand your business or distribute your product in

Indonesia, you have to apply for licenses and register your product first.

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

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1. Product Registration under Your Legal Entity in IndonesiaForeign 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.

Product Registration in Indonesia

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2. Product Registration under Appointed Local DistributorsThis 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.

Product Registration in Indonesia

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3. Product Registrations under proper Third PartyThe 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. In this case, 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

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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.

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Product Registration in Indonesia

Cekindo Process Flow for Product Registration

Cekindo Pre assessment & coordination

Government Regulators

Returned o be completed

Additional data required

evaluation

Customer

No Approve

Bank paymentt

Customer

Approval of Registered Product

changes

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Medical device and household product registration in Indonesia 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

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.

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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

Medical device and household product registration in Indonesia

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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.

Food and drug registration in Indonesia

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The registration must be done by the local company, local agent or distributor before the products clear Indonesian customs. Especially for cosmetic registration approval, Indonesia follows the ASEAN Harmonized Cosmetic Regulatory Scheme.

For imported food, it is a must to apply for a ML registration 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.

Food and drug registrationin Indonesia

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Trademark registration in Indonesia is regulated by Trademark Act No. 15 Year 2001. Trademark 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.

Trademark Registration in Indonesia

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PT. Cekindo Bisnis GrupMenara BCA Grand Indonesia 50th fl

Jl. MH. Thamrin No. 1Jakarta Pusat 10310, Indonesia

info@cekindo.com/ +6221 580 6889cekindo.com

Why Cekindo?

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PT. Cekindo Bisnis Grup is a market entry consulting firm in Central Jakarta, providing one-stop

services to assist foreign companies from various industries in expanding to Indonesia and beyond

Our main services, include Business Set Up, Business Process Outsourcing, and Local

Representation; more info on www.cekindo.com

Our dynamic multinational team based in Jakarta to understand the local market and utilize our

extensive network to support our client’s business and operation in Indonesia

PT. Cekindo Bisnis GrupMenara BCA Grand Indonesia 50th fl

Jl. MH. Thamrin No. 1Jakarta Pusat 10310, Indonesia

info@cekindo.com/ +6221 580 6889cekindo.com

Contact Us

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