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InCorp offers a comprehensive range of solutions to ease the company registration process and help you create a viable roadmap for your business.
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.
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.
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 country’s 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.
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.
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.
InCorp can help foreigners to get the driving license in Indonesia, whether SIM A or SIM C. Check out the requirements and the procedure, here.
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 thriving population, growing economy, and still largely underdeveloped health sector make the perfect combination for up-and-coming businesses with medical products.
Currently, the Indonesian government is boosting the local medical device production to encourage increased spending on domestic products. However, due to raw materials and technology limitations, some types of medical devices still depend on imported products.
It brings bright prospects for foreign manufacturers looking for new profitable markets. There is, however, a wide range of precautions anyone considering trading in this highly regulated area should know.
Since domestic production is mostly oriented toward some disposable items, other consumable medical products, high value-added products, and sophisticated devices must be imported.
The Ministry of Health of the Republic of Indonesia (MoH) defines medical devices and products as instruments, apparatuses, machines, and/or implants that do not contain drugs 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.
This general definition is stated in Article 1 of MoH Regulation No. 62 Year 2017 regarding The Distribution License of Medical Devices, In Vitro Diagnostic and Household Health Supplies issued by the Director General of Pharmacy and Medical Devices of the Indonesian Ministry of Health.
Entrepreneurs aspiring to trade medical devices in Indonesia must prove that they are in possession of several licenses before going through the medical device registration in Indonesia with the Ministry of Health. The crucial documents are:
Foreign companies cannot distribute medical products in Indonesia unless they establish a limited company with direct foreign investment (PT PMA) or find a local distributor. A permanent Business License issued by Investment Coordinating Board (BKPM) is one of the prerequisites to starting a PT PMA.
Furthermore, to enter the healthcare sector, entrepreneurs should be aware of the Positive Investment List that regulates the maximum percentage of foreign shares in the company. In the healthcare sector, the maximum of foreign shares is 49%.
With the harmonization at the level of ASEAN in the field of medical devices and the publication of guidelines for medical devices on the ASEAN Medical Device Directive, Indonesia actively participates in the ASEAN Conformity Committee for Standard and Quality Medical Devices Product Working Group (ACCSQ-MDPWG). The ASEAN Medical Device Directive has been implemented for registering medical devices and household health supplies in Indonesia.
Medical device registration applications must be prepared using the Common Submission Dossier Template (CSDT) format. The ASEAN CSDT document aims to provide a standard template for the submission of medical device information to the regulatory authorities of ASEAN member countries.
The license confirms that a product meets both Indonesian and international quality, effectiveness, and safety standards. ISO 13485:2016 is a required certificate for quality management systems. 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 still need to 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:
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 that previously took up to five months in total.
All business entities are required to register through the OSS. Once the registration process is completed, a Business Identification Number (NIB) is issued automatically. The NIB serves as 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, to some extent, facilitated by the harmonization of 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.
Devices and products that do not present any severe harm if mishandled include medical cotton, bandage, gauze, sanitary pads, walking canes, and more expensive equipment such as wheelchairs or special adjustable beds. This is a vast group, and evaluating these products focuses primarily on their quality and durability.
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.
If operated without the necessary expertise, sophisticated devices may pose a severe yet not fatal threat to a patient’s health. X Rays, ECGs, in-patient monitoring systems, orthopedic implants, contact lenses, oximeters, and many other devices fall under this class. These products will undergo a complex evaluation that includes risk analysis, and the producer is expected to provide security facts. Nevertheless, clinical tests are still not needed.
Unprofessional manipulation and usage of these products and devices can result in severe or fatal consequences for the patient or medical staff. CT scans, MRIs, cardiac catheters, cardiac stents, HIV tests, pacemakers, dermal fillers, and many other medical instruments pose a high risk. They, therefore, have to go through a long process of evaluation before they can be distributed.
In addition, clinical tests, articles in published journals, and risk analysis have to be executed and security facts provided to ensure a smooth approval. Please note that the evaluation is subject to a charge. The amount depends on the class assigned, and it is due before proceeding further with the paperwork.
Even the registered products in their origin country cannot be considered for the Indonesian market unless you are granted the Distribution License for Medical Devices (NIE) issued by the MoH. An NIE requires manufacturers to comply with approved labeling/packaging requirements and ensure that they meet specific qualities for each product. An e-report regarding your product should be submitted every six months.
Besides the basic information such as product name, batch number/production number, and expiry date, additional data about manufacturer and distributor should be provided. The Ministry of Health also requires the IFU translation from the original language into Indonesian.
As the conditions vary a lot for different types of products, it might be challenging to follow the compliance and not fall behind schedule when it comes to red tape. You should consider an experienced company such as Cekindo to be in charge to make sure the legal proceedings go as smoothly as possible.
After the product is launched, it remains under the authorities’ control. Monitoring is conducted according to the AMDD guidelines, and it includes sampling, vigilance, and advertising to ensure permanent quality.
To find out more about opportunities the Indonesian boosting healthcare sector may offer to you or for help with establishing your product within the local market, please contact Cekindo. Our experts will guide you through medical product registration in Indonesia.
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.