- July 5, 2018
- Posted by: Hilda Saputra
- Category: Uncategorized
In order to guarantee the quality and safety of medical devices in Indonesia, The Ministry of Health of Republic Indonesia has issued several regulation as guideline for the circulation of medical devices in Indonesia. Under Law no. 36 Year 2009 on Health, pharmaceutical products and medical devices can only be circulated after obtaining marketing authorization.
Marketing Authorization is a certification issued by The Ministry of Health that allow medical products to be distributed on the market after evaluation for safety, efficacy and quality by authorized officials. Types of application for medical devices marketing authorization include:
- Application for New Product of Medical Device
- Application for Renewal of Medical Device
- Application for Variation of Medical Device
- Application for Renewal with Variation of Medical Device
It is important to take note that before you can register your medical devices for marketing authorization, you need to be certified as medical devices distributor. To obtain the certification (IPAK), you have to apply for recommendation from BTSP and then you can register to Ministry of health.
Once you obtain your IPAK, you will be provided with an account. You can register your medical devices for marketing authorization through this account. The authorized official will determine the classification of your medical devices. Regulation of Minister Health of Republic Indonesia number 62 year 2017 on Marketing Authorization of Medical Devices classified medical devices into four classification:
- Class A for low risk medical devices.
- Class B for low-medium risk medical devices.
- Class C for medium-high risk medical devices.
- Class D for high risk medical devices.
The duration for market authorization process ranges from 45-120 days, depending on the classification of your medical devices.
Requirements for application of marketing authorization of medical devices distribution are:
- Registration form
- Form A which consist of Administrative Data
- Form B , which consist of description of medical devices
- Form C, which consist of Information Specification and Quality Assurance of the medical devices
- Form D, which consist of the Instructions on how to use the medical devices
- Form E , which consist of post market evaluation
There are several medical devices that require special requirement:
- Medical devices that contain and/or transmit radiation shall get license from Nuclear Energy Regulatory Agency of Indonesia (BAPETEN).
- Disposable sterile syringe products should be tested for sterility in accredited laboratories in Indonesia.
- Gauze products, cotton, panty liner, sanitary napkins, and adult diapers should be tested fluorescence and absorption in an accredited laboratory in Indonesia.
- Condom products should be tested for leakage in an accredited laboratory in Indonesia.
- The application of HIV test product should attach the clinical results from RSCM (Indonesian National Hospital).
- The application of disinfectant product should attach the coefficient test result.