BUSINESS SET UP IN INDONESIA In Indonesia, if you want to expand your business or distribute your product, you have to apply for licenses and register your products. We at Cekindo can help you by explaining the product registration process. Contact us http://www.cekindo.com/contact.html

1. Entry Market in Indonesia
Product Registration
cekindo.com
Since 2012

2. 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:
cekindo.com

3. 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.
Product Registration in Indonesia
cekindo.com

4. 2. Product Registration 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.
Product Registration in Indonesia
cekindo.com

5. 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. 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
cekindo.com

6. 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.com
Product Registration in Indonesia

7. 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
cekindo.com

8. 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.
cekindo.com

9.  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
cekindo.com

10.  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
cekindo.com

11.  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 registration
in Indonesia
cekindo.com

12.  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
cekindo.com

13. PT. Cekindo Bisnis Grup
Menara BCA Grand Indonesia 50th fl
Jl. MH. Thamrin No. 1
Jakarta Pusat 10310, Indonesia
info@cekindo.com/ +6221 580 6889
cekindo.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

14. PT. Cekindo Bisnis Grup
Menara BCA Grand Indonesia 50th fl
Jl. MH. Thamrin No. 1
Jakarta Pusat 10310, Indonesia
info@cekindo.com/ +6221 580 6889
cekindo.com
Contact Us
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