The Indonesian Ministry of Health has issued a guidebook for Public Service Guidelines for Circulation of Medical Devices and Household Health Supplies During the Covid-19 Pandemic Conditions in 2020. This manual book discusses List of products, Service Flow/Time and document requirements for registration of COVID-19 related medical devices.
1. The following is a list of Medical Devices, IVD and Household Health Supplies for handling COVID-19:
1. Surgical Face Mask
2. N95 mask
3. Isolation gown (APD Gown)
4. Liquid Chemical Sterilant/ High Level Disinfectants
5. Surgeon’s Glove
6. Patient Examination Glove
7. Clinical Electronic Thermometer
9. Infusion Pump
10. Mobile X-Ray
11. High Flow Oxygen Device
12. Portable bronchoscopy
13. Power Air Purifying Respirator
14. CPAP Mask
15. CPAP Machine
16. ECMO (Extracorporeal Membrane Oxygenation)
17. Breathing Circuit for Ventilator and CPAP
18. Neonatal Incubator and Incubator Transport
19. Transport Culture Medium (VTM / UTM)
20. Microbiological Specimen Collection and Transport Device (Dacron Swab)
21. Reagent / Rapid Test Equipment / Instrument * for COVID-19 Examination
22. Resuscitation Bag
23. Hand Sanitizer and Disinfectant
*) For Rapid Test specifically only domestic products
For above mentioned products, applicant can choose to register the product with MoH to get marketing authorization license prior importation or do importation through National Disaster Management Agency (in Indonesia: BNBP) by applying Import Recommendation.
For medical device registration with MoH, MoH provide One Day Service so the applicant can get marketing authorization license soon upon provide complete documents to MoH.
Besides, MoH also makes some adjustments to the document requirements during the COVID-19 pandemic conditions such as Legalization of LOA by the Indonesian Embassy in the country of origin can be provided later after approval by attaching a stamped statement letter, for class A products it can use QMS ISO 9001 only, Summary of design verification and validation documents only for Sterile Medical Devices/DIV and Executive Summary won’t be needed.
Public Service Guidelines Marketing Authorization of Medical Devices and Household Supply During The Covid-19 Pandemic Conditions
Indonesia Registration Introduction
INDONESIA: Grouping Medical Devices in Indonesia – Aug, 2020