Regulatory Consultant

• Medical Device Distribution License
  To guarantee security, quality, and benefits of imported or domestically-produced medical devices distributed in Indonesia, there is a requirement to control Medical devices. In accordance with Law Number 36 of 2009 on Health, Article 106 paragraph (1) stating that the provision of pharmaceuticals and Medical devices may only be performed after acquiring a distribution license from the Ministry of Health of the Republic of Indonesia. The medical devices are grouped into four classes, namely, Class A (low risk), Class B (low – medium risk), Class C (medium – high risk), and Class D (high risk).

  Service of medical device distribution license consists of:
  1. New Application
  2. Renewal
  3. Revision
  4. Renewal with revision

• Medical device Distribution Certificate/IPAK
  In accordance with the Regulation of the Minister of Health Number 1191/Menkes/Per/VIII/2010 on the Distribution of Medical devices, the distribution of such devices may only be performed by an entity possessing Medical device Distribution Certificate/IPAK from the Ministry of Health.
  Such medical devices listed on the Medical device Distribution Certificate/IPAK are classified into 5 (five) categories: Radiation Electromedical Medical device, Non-Radiation Electromedical Medical device, Sterile Non-Electromedical Medical device, Non-Sterile Non-Electromedical Medical device, and In-Vitro Diagnostic Product.

• Medical device Production Certificate and PKRT
  In accordance with the Regulation of the Minister of Health Number 1189/Menkes/Per/VIII/2010 on the production of medical devices (Alkes) and the Domestic Household Health (PKRT) may only be performed by a company holding a production certificate from the Indonesian Ministry of Health.

• License Holding
  It is specifically aimed at a company holding a brand/product wishing to enter Indonesia market or an overseas company which may not wish/have not decided to operate in Indonesia. Medical device distribution license will be registered under the name of KSI which has a medical device distribution certificate.
  The benefit of license holding is that the principal may control the price in the market, open and develop marketable product lines, save product marketing costs, and improve revenue, development, and growth on product sales.

• Company Registration
  This is aimed at Foreign Investors (PMA) wishing to establish or open a branch office in Indonesia or to establish a local company.

• Warehousing
  This is aimed at domestic or overseas companies requiring warehouses to stock their products.
  KSI has a warehousing management solution to handle provision solution with close relationship with demand cycle and cost optimization.

• E-Catalog
  The procurement of goods/services in the government sector based on the Presidential Regulation Number 54 of 2010 on the Procurement of Government’s Goods/Services in which the system provides information on products such as pricing, specification, and official sales distribution paths.
  Government’s goods/service e-procurement performed through the information technology and electronic transaction adheres to regulatory stipulations.

• Registration Certificate (STP)
  Based on the regulation of the Indonesian Minister of Trade Number 11/M-DAG/PER-3/2006 which explains that the Registration Certificate (STP) is the proof that a company has been registered as an Agent, Sole Agent, Sub-Agent, Sole-Distributor, or Sub-Distributor of goods/services whose license is provided by the Director of Business and Company Registration of the Ministry of Trade.

• Sterility Test
  Disposable sterile syringe products must undergo sterility testing at an accredited laboratory in Indonesia before the Distribution License of such product may be registered in the Indonesian Ministry of Health.

• Fluorescent Test
  Gauze, cotton, pantyliner, sanitary napkin, and adult diaper products must be tested for fluorescence and absorption at an accredited laboratory in Indonesia before the product’s distribution license is registered in the Indonesian Ministry of Health.

HALAL means permissible; a deeper meaning is that any object or activity that is allowed to be used or practiced in Islam. The opposite of the word HALAL is HARAM, meaning forbidden.

Products containing alcohol, animal carcasses, blood and pork are forbidden to use and consume.

To increase the confidence and security of products marketed in Indonesia, in accordance with Law No. 26 of 2019 on the Implementation of Halal Product Guarantees, the following products are recommended to obtain halal certificates:

• Medical devices.

• Food & Beverages.

• Medicines.

• Cosmetics.

• Wearable items in the categories of clothing, headgear, and accessories.

• Usable items in the categories of household health supplies, household equipment, worship equipment for Moslem, stationery, and office supplies.

In carrying out distribution activities, every Medical Device Distributor and Medical Device Distributor Branch must implement the Prudent Medical Device Distribution Method (CDAKB) based on the Regulation of the Indonesian Minister of Health Number 4 of 2014 on the Prudent Medical Device Distribution Method (CDAKB). Application of CDAKB is to guarantee Medical Device products that meet safety, benefits, and quality requirements in order to protect the public from improper distribution of medical devices.

The medical devices included in the mandatory category of CDAKB in the Regulation of the Minister of Health No 4 of 2014 are:

• Radiation electromedical medical devices.
• Non-radiation electromedical medical devices.
• Sterile non-electromedical medical devices.
• Non-sterile non-electromedical medical devices.
• In-vitro diagnostic medical devices.