Related Guide Documents Required for Medical Device Registration in Indonesia Full document checklist based on the official Pedoman Pelayanan Izin Edar Alat Kesehatan (Guidelines for
Table of Contents Introduction What Is IDAK Registration? Who Needs to Apply for IDAK? Step-by-Step IDAK Registration Process Documents Required for IDAK Registration How Long
Table of Contents What Is Medical Device Classification in Indonesia? Why Medical Device Classification Is Important for Registration Overview of Medical Device Classes in Indonesia
Table of Contents Understanding Medical Devices as Regulated Products Why Medical Device Registration is Mandatory Medical Device Classification System Prerequisites: What You Need Before Registration
1. Thermometer as a Medical Device Thermometers are essential tools in healthcare and home use for measuring body temperature — a key Thermometers are essential
Toothbrush Classification in Indonesia Toothbrushes are commonly classified as Dental Equipment under Indonesian medical device regulations, with the following classification: ⚠️ Note: This is the
Sanitary pads and pantyliners are classified as Obstetric and Gynecological Devices under Indonesian medical device regulations, with the following classification: Although widely considered consumer products,
Medical Mask as a Medical Device The demand and sales of medical masks have significantly increased since the COVID-19 pandemic, not only in hospitals and
Knee Support as a Medical Device A knee support, also known as a knee brace, is a non-implant orthopedic device that supports, stabilizes, and protects
Overview Indonesia, as the world’s largest Muslim-majority country, has made halal product assurance a national priority. This includes medical devices — both imported and locally
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