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Posts Tagged ‘indonesia’

Licenses and Product Registration in Indonesia – In Indonesia the National Agency of Drug and Food Control (NA-DFC) is responsible for regulating pharmaceuticals products and drugs in Indonesia. Primary functions of NA-DFC include pre-market evaluation of medical products, legislation, regulation, standardization, and GMP certification. 

The criteria and guidelines for registration in Indonesia were last updated in 2011. It is based on assessment of the drug’s risk, quality, safety and efficacy and need of people. The drug registration application in Indonesia can only be done by pharmaceutical companies located in Indonesia through a pre-registration process, which takes around 40 working days. It involves consultation on completeness of registration dossier and document and registration fees.

 

Medical Device Registration in IndonesiaRegulatory authority: In Indonesia, medical devices are regulated by the Directorate General of Pharmaceutical and Medical Devices under the Ministry of Health (MOH). Medical products, whether they are manufactured or imported into Indonesia, must be registered with the MOH.

Classification: Medical devices in Indonesia are divided into three classes (I, II and III) based on risk level, with Class I being the lowest risk and Class III the highest risk.

To register a medical device, a company must have an office or a local distributor in Indonesia registered with the MOH.

Timeframe of registration: Medical devices are registered according to class within 30, 60, or 90 working days after the pre-registration process is complete.

Length of license: Licenses issued in Indonesia expire within 2-5 years, depending on the period of the Letter of Authorization. 

Feel free to contact us and get a free quotation for Product Registration in Indonesia

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Company Registration in Indonesia – Indonesia is your investment destination. Abundant natural resources, a young and technically trained work force and a large and growing domestic market, combined with an improving investment climate and a higher global profile, are just a few of Indonesia’s salient strengths. With stability firmly planted after 16 years of vibrant democratic rule, Indonesia’s vast economic potential is primed for takeoff. 

All foreign owned companies in Indonesia are classified as PT PMA-s (stands for limited liability company with foreign direct investment). A company is a PMA as long as any of the shares are owned by foreigners.
 

Setting up Business Activities and a Company in Indonesia

To establish a business in Indonesia, you have a range of options depending on your need. If you are to sell products or services without the need for your own presence in Indonesia, you could choose to appoint an Agent or Distributor. Alternatively, you could set up a Representative Office. A Representative Office allows you a legal presence in Indonesia, but it is not allowed to undertake business transactions or receive sales payments in Indonesia.

Representative Office

A Representative Office can be established depending upon the line of business and the necessary licenses issued by the related government department. The critical limitation of a Representative Office is that they are not allowed to conduct direct sales and cannot issue Bills of Lading.
Representative Offices are set up primarily for marketing, market research, or as buying or selling agents. Most businesses quickly find the Representative Offices very limiting. It’s often more time and cost effective to form an Indonesian company right from the start.

Limited Liability Co or Perseroan Terbatas (PT)

All PMA companies in Indonesia must take the form of a limited liability establishment (PT). Other business forms, such as CV and UD, are reserved for Indonesians only.

Any company owning any percentage of foreign shareholding is a PMA company. 100% foreign-owned PMA companies are possible in many cases, but some sectors require a proportion of Indonesian shareholding, as determined within the Negative List of Investment (DNI).

Incorporation of PMA Company

Under the current foreign investment regime, the Investment Coordinating Board (BKPM) is the government body which processes and handles FDI administration and licensing.

 

Feel free to contact us and get a free quotation for Company Registration in Indonesia.

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