- Product Registration
The improvement of the healthcare system in Indonesia requires more modern medical devices.
Indonesian people are open for new foods and beverages, which provides wide opportunities for foreign business players.
Following the trend of healthy lifestyle in Indonesia, the market for food supplement is growing bigger.
The biggest consumer of cosmetic products in Indonesia are the people who live in big cities.
To register your products in Indonesia you must have a legal entity in the country 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.
#1 Product Registration under Your Legal Entity in Indonesia; foreign company that has 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. Learn more about company registration in Indonesia.
#2 Product Registration under Appointed Local Distributor; this option might another alternative if there is no intention to set up a legal entity in Indonesia but you wish to distribute products in the Indonesian market. This local distributor should be selected properly because in accordance with the government’s regulations, there can only be one acknowledged official distributor. Moreover, the appointed distributor will be responsible for product registration as well as penetrating local market and will be the license holder for 3-5 years. If the appointed local distributor doesn’t perform well, the market for this product can be closed for several years.
#3 Product Registration under proper Third Party; the third option might work for foreign companies without sufficient information about local distributor in Indonesia and also to minimize risks if the distributor’s performance is below expectation. This third party can be a Consultant Company that has already had licenses to register certain products.
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 a third party that can officially act as an 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 in the business. An advantage of registering your product under third party is that you will have your business in Indonesia under full control and it will be flexible to cooperate with more local distributors in the Indonesian market at the same time.
Product registration in Indonesia is under control of the Ministry of Health and an independent agency named National Agency of Drug and Food Control (BPOM). For medical devices and household product, you should directly register to the Ministry of Health to get the distribution license. While for cosmetic, food supplement, food and beverage, drug and traditional medicine, they are registered to the National Agency of Drug and Food Control.
Cekindo Process Flow for Product Registration
Medical device registration in Indonesia is one of the most highly regulated in Indonesia. Medical manufacturers and Indonesian medical distributors must 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 under the risk-based class and this categorization will also influence the registration process period. 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 is 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. Applicant can be a:
All food and drug products, including drugs, traditional medicines, cosmetics, food supplements 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 a local company, local agent or distributor before the products are cleared by the 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 foods, 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 every 5 years. While 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, it is strictly regulated in Indonesia and it can take 1-3 years to complete as the Indonesian government considers local manufactured drugs instead of imported drugs.
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.
Feel free to contact us for a free quotation for Product Registration in Indonesia.