InCorp offers a comprehensive range of solutions to ease the company registration process and help you create a viable roadmap for your business.
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Get assistance from experts with a decade of experience in assisting international business owners expanding into Indonesia.
Avoid any bureaucratic complexity when closing your company by engaging with our experienced legal advisors.
What type of legal entities should you choose to register a company in Indonesia? We can assist you in choosing which is the best one to grow your business.
To help businesses survive during this unfortunate time, InCorp provides corporate recovery in Indonesia and insolvency services.
Granting an environmental permit in Indonesia needs an Environmental Impact Analysis (AMDAL) in advance.
Obtaining property & land ownership in Indonesia offers some challenges for foreigners. However, buying property in Indonesia is attainable with specific resources and documents.
Recent regulatory changes have a knock-on effect on Indonesia's Merger & Acquisition landscape. Check on how we can navigate you through your M&A in Indonesia.
InCorp provides Virtual Office services Indonesia in various locations: Jakarta, Bali, Semarang, Surabaya, and Batam.
Applying for a B3 waste permit in Indonesia is important to ensure your business aligns with government regulations.
Business process outsourcing in Indonesia is a viable option to streamline bureaucratic complexities that hurdle your business expansion objectives.
InCorp offers a complete range of accounting service Indonesia, from tax reporting to auditing.
With professional financial audit services from InCorp, you can ensure all accounting activities are accurately recorded and compliant with Indonesian regulations.
Using an Employer of Record service to set your roots in Indonesia opens the doors to new opportunities in the country.
Financial and Operational Resilience services from InCorp are developed to support businesses and help them survive during this difficult time.
Payroll services in Indonesia are a practical solution to avoid unnecessary complexities while you focus on growing your business.
Using a recruitment agency in Indonesia will help you hire the best candidates for your company, saving you time and money.
Tax consulting in Indonesia are the shortcuts to fulfill the administrative obligations with high accuracy and in a timely manner.
The Indonesian government promotes tax holidays as one of the fiscal incentives to attract major foreign direct investment in Indonesia.
Operating businesses in Indonesia, entrepreneurs must comply with the regulations accordingly, especially concerning taxes.
Our expert consultants on tax reporting services in Indonesia ensure prompt fulfillment of administrative obligations with utmost accuracy.
Streamline your global business operations with a Global Mobility Service as one complete solution from InCorp Indonesia.
Immigration in Indonesia is one of the strictest and most complex processes due to its ever-changing regulations. InCorp provides a seamless experience in obtaining your stay and work permits.
Avoid any hassles by engaging with an experienced visa agent in Indonesia.
A dependent visa Indonesia is a document that allows foreigners to bring their family while settling down in the country.
Investor KITAS Indonesia is a stay permit that offers many benefits to investors that invest in the country.
Overseas Visas are required for Indonesians who are planning to stay abroad for an extended period of time.
KITAP is a permanent stay visa for foreigners who have intentions to stay in Indonesia.
Foreign retirees often find their plans stuck due to the complex visa application process. InCorp helps expedite the process.
Obtaining a social visa is daunting if you are not familiar with the countrys complex bureaucratic processes. Consult with us for a seamless Indonesian visa application experience.
Foreigners married to an Indonesian citizen are eligible for a spouse-sponsored KITAS.
Learn how to obtain an Indonesian tourist visa seamlessly and securely, directly from a trusted visa and travel agent.
Get assistance from a trusted visa agent in Indonesia to make your traveling plan to Indonesia even more convenient.
Expedite your Indonesian work permit application process by engaging with a trusted visa agent.
If you’re a member of the Indonesian diaspora and have lost your citizenship, you can get a diaspora visa to return home more quickly. InCorp Indonesia can help you take full advantage of this benefit.
All imported goods must obtain permission granted by specific governing bodies prior to entering the local market.
Learn more about the cosmetic product registration services in Indonesia.
Learn more about exporting goods to Indonesia.
Learn more about the food & beverage product registration services in Indonesia
Learn how to go through halal certification in Indonesia directly from experts successfully.
Learn more about the health supplement product registration services in Indonesia.
Learn more about the household product registration services in Indonesia.
Learn more about importing goods from Indonesia
An Importer of Record in Indonesia is a legal service that enables companies to import products into Indonesia, through an import partner.
Learn more about the medical device registration services in Indonesia.
Learn more about the SNI registration services in Indonesia.
Register a trademark is necessary to avoid legal issues in the future. InCorp can help you with Trademark Registration services in Indonesia.
Compliance is one of the most challenging parts of business overseas, especially in a country packed with complex bureaucratic processes such as Indonesia.
Updating business documents to align with your company’s growth can be a hassle.
Due Diligence services are needed to assess the credibility of the company or partner you wish to work with or acquire in Indonesia
From Company Regulations to Employment Agreement Drafting, Employment law services from InCorp will help you to compliance with employment policy in Indonesia.
InCorp’s legal consultation services in Indonesia are crafted to help your business settle and fully comply with the latest regulations.
Organizations must continuously evolve and transform to remain competitive and relevant in todays global environment ...
Companies face many opportunities and challenges as a result of a changing market and regulatory landscape ...
Adopting Environmental, Social, and Corporate Governance (ESG) practices can improve your company’s value ...
Risk Management services from InCorp Indonesia can assist companies in building confidence when making future business decisions ...
Transfer Pricing in Indonesia occurs when a company performs an internal transaction within the same business group or its subsidiaries
InCorp's transfer pricing advisory services in Indonesia are marked by the objective to support our clients' business needs.
Our transfer pricing services provide you with a hassle-free experience while still complying with the legal aspects of transfer pricing in Indonesia.
As the market-entry consulting firm in Indonesia, InCorp provides a wide range of customized solutions to ease the business incorporation process.
Both natural and legal persons are entitled to open a bank account in Indonesia. Find out how to open a bank account in Indonesia, here.
InCorp can help you find a trusted Buying Agent Indonesia for product sourcing in Indonesia. Contact us now for a free consultation.
IMEI Registration in Indonesia is necessary to ensure telecommunication devices from abroad can function properly in Indonesia.
With offices in Jakarta, Bali, Semarang, SUrabaya, and Batam, InCorp is ready to assist you as a local partner and distributor in Indonesia.
InCorp can help you to select the trusted local partners to import and distribute your products in Indonesia.
Improve your business by knowing the market conditions in Indonesia through market research services in Indonesia.
InCorp can help you gain information about your competitor's product through mystery shopping.
Indonesia’s healthcare sector has great potential for growth. The government is encouraging local medical device production, but there are limitations due to a lack of raw materials and technological advancements.
Foreign manufacturers should exploit this moment to explore new, profitable markets. However, trading in the medical industry requires awareness of regulations. Importing is essential for high-value-added products and intricate devices, as domestic production focuses on disposable items.
The Ministry of Health of the Republic of Indonesia defines medical devices and products as instruments, apparatuses, machines, and/or implants. These items are used to prevent, diagnose, cure, and relieve diseases, treat sick people, recover the health of human beings, and/or form the structure and correct the body function, and they do not contain drugs.
This broad definition can be found in Article 1 of MoH Regulation No. 62 Year 2017, which deals with the Distribution License of Medical Devices, In Vitro Diagnostic, and Household Health Supplies. This regulation is issued by the Director General of Pharmacy and Medical Devices at the Indonesian Ministry of Health.
To complete the registration of a medical device in Indonesia, adhere to the ASEAN Common Submission Dossier Template (CSDT) by providing the following documentation:
Ensuring the submission of these documents is crucial for a successful medical device registration process in Indonesia.
Before registering medical devices in Indonesia, entrepreneurs aspiring to trade them must prove that they own several licenses from the Ministry of Health. The crucial documents include:
Foreign companies can only distribute medical products in Indonesia if they establish a limited company with direct foreign investment (PT PMA) or find a local distributor. Your company also needs a permanent Business License from the Ministry of Investment (BKPM) as one of the prerequisites to starting a PT PMA.
Furthermore, entrepreneurs should know about the Positive Investment List to enter the healthcare sector. The list has regulations on the company’s maximum percentage of foreign shares. In the healthcare sector (Pharmaceutical industry and Hospital), regulatory amendments have allowed foreigners to possess full ownership—up to 100%—of shares.
Indonesia participates in the ASEAN Conformity Committee for Standard and Quality Medical Devices Product Working Group (ACCSQ-MDPWG). With that, Indonesia actively contributes to harmonizing medical device regulations within ASEAN. This collaboration involves the development of guidelines for medical devices based on the ASEAN Medical Device Directive.
The ASEAN Medical Device Directive regulates medical device and household health supply registration in Indonesia. The Common Submission Dossier Template (CSDT) is the standard format for registration, providing a uniform template for submitting medical device information to ASEAN regulatory authorities.
The license confirms that a product meets Indonesian and international quality, effectiveness, and safety standards, which is an. ISO 13485:2016. It is a quality management systems certification. An organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
A medical device distributor in the form of a legal entity should be licensed to perform a series of distribution or delivery activities with a Medical Devices Distributor License (IDAK). There also should be a dedicated person who acts as a Technical Responsible Person with sufficient educational background according to the medical device category, such as:
Nevertheless, further steps must be taken before signing your first business deal.
To register a medical device in Indonesia, you are required to submit an online application with the following documents:
As of 1 January 2024, CPAKB (Cara Pembuatan Alat Kesehatan yang Baik) certificate is mandatory for companies that produce and distribute medical devices. CPAKB is a guideline used in various activities to manufacture Medical Devices and quality control. It aims to ensure that the produced medical device products meet the requirements of their intended use
To register a medical device, the procedure is as follows:
The government has implemented the Online Single Submission (OSS) system since July 2018 to shorten the process of securing an import license. All business entities are required to register through the OSS. Once completed, a Business Identification Number (NIB) is issued automatically.
The NIB is the basic Import License and replaces the Company Registration Certificate (TDP) and Importer Identification Number (API).
The long and highly bureaucratic market-entering process has been facilitated by harmonizing Indonesian regulations with the rest of the ASEAN countries under the Medical Device Directive (AMDD).
In addition, the AMDD has changed the classification of medical products based on the risk they can cause if mishandled. A four-grade evaluation system has replaced the former three categories.
There’s a wide range of medical items, like medical cotton, bandages, gauze, sanitary pads, walking canes, and even more substantial equipment such as wheelchairs and adjustable beds. These products generally don’t pose significant risks if misused. When assessing them, the main concerns are quality and how long they last.
Products and devices that could impact the patient’s health in case of malfunction or if not used properly. This includes electric hospital beds, surgical masks, gloves, syringes, and hemodialysis fluids. Clinical tests are not involved in the evaluation of medical instruments. A set of requirements has to be met.
Medical devices like X-rays, ECGs, monitoring systems, implants, and oximeters can harm patients if not used by experts. While not life-threatening, they require safe operation expertise and risk analysis. Manufacturers must provide safety information, but clinical tests are not mandatory.
Certain medical products and devices can be risky and require thorough evaluation before distribution. Manufacturers must conduct clinical tests, publish articles, and perform risk analysis to gain approval.
This evaluation process comes with a fee that depends on the device’s classification and must be paid before proceeding with the necessary paperwork.
Benefits of having an Independent License Holder for a medical device in Indonesia:
For assistance in navigating medical device regulations in Indonesia, Asia Actual is ready to provide support.
Obtaining a Distribution License for Medical Devices (NIE) issued by the MoH is mandatory to sell medical devices in Indonesia. You must ensure your products comply with approved labeling and packaging requirements and meet specific quality standards.
Also, you must submit an e-report every six months containing basic information such as product name, batch number/production number, and expiry date. If you need any assistance with compliance and legal proceedings, feel free to contact InCorp Indonesia.
After the product is launched, it remains under the authorities’ control. Monitoring is conducted according to the AMDD guidelines, including sampling, vigilance, and advertising to ensure permanent quality.
To take advantage of the thriving opportunities in Indonesia’s healthcare sector and successfully register your medical products, contact InCorp Indonesia today. Our experienced team is ready to guide you through the complex process, ensuring compliance with all regulations.
Don’t miss out on the chance to tap into this underdeveloped market. Fill out the form below, and let InCorp Indonesia be your partner in navigating the intricate landscape of Indonesia’s medical device registration.
An expert for more than 10 years, Pandu Biasramadhan, has an extensive background in providing top-quality and comprehensive business solutions for enterprises in Indonesia and managing regional partnership channels across Southeast Asia.
Disclaimer: The information is provided by PT. Cekindo Business International (“InCorp Indonesia/ we”) for general purpose only and we make no representations or warranties of any kind.
We do not act as an authorized government or non-government provider for official documents and services, which is issued by the Government of the Republic of Indonesia or its appointed officials.
We do not promote any official government document or services of the Government of the Republic of Indonesia, including but not limited to, business identifiers, health and welfare assistance programs and benefits, unclaimed tax rebate, electronic travel visa and authorization, passports in this website.
Yes, license holder and distributor of medical devices must have Medical Device Distribution License (Izin Penyalur Alat Kesehatan/IPAK).
There will be specific documents from Manufacturing/Factory, Indonesian Legal Entity, and Product documents. Contact InCorp Indonesia for more details.
The medical devices license called Izin Edar Alat Kesehatan (AKL) will be valid up to 5 years, depending on the Letter of Authorization from the Principle (product owner).
Yes, there are 2 options you may choose. The first option is appointing an existing distributor and the second option is appointing InCorp Indonesia to be the license holder.