Home Blog Medical Device Registration in Indonesia – 2021 Update Group1 | Product Registration Medical Device Registration in Indonesia – 2021 Update InCorp Editorial Team 10 March 2014 6 minute reading time Table of Contents The Urgency to Improve Indonesia’s Healthcare System Government Agenda to Reform Indonesia’s Healthcare System Indonesia Medical Device Registration - Opportunities for Foreign Investment Indonesia Medical Device Registration - A Step-by-Step Guide Process and Requirements of Medical Device Registration in Indonesia Indonesia Medical Device Registration - Is Halal Certification required? Registering Your Medical Devices with Cekindo The Urgency to Improve Indonesia’s Healthcare System Indonesia’s healthcare sector has increased in terms of size and accessibility in recent years, however, the industry’s quality and capacity remain fragile. With a significant shortage of hospital beds (12 beds per 10,000 people), medical staff, and intensive care facilities, the healthcare system is under massive stress. Furthermore, Covid-19 has aggravated the situation by causing a rapid increase in demand for medical services, for which there are no provisions. There is an eminent urgency to improve Indonesia’s healthcare system, thus creating a great scenario for investment in the medical industry. This article provides a complete guide on opportunities in the healthcare sector and understanding procedures for medical device registration Indonesia. Government Agenda to Reform Indonesia’s Healthcare System Improving Healthcare Facilities The government has addressed some administrative reforms to increase the rate of hospital bed per person, by liberating healthcare-related sectors for 100% foreign investment through the new Positive Investment List: Business Line Previous Regulation Positive Investment List Hospital 67% foreign ownership (70% for ASEAN investors) Open for 100% foreign ownership for the hospital with a minimum number of 200 beds Medical Device Distributor Maximum 49% foreign ownership Open for 100% foreign ownership Medical Device Testing Maximum 67% foreign ownership Open for 100% foreign ownership Indonesia Medical Device Registration – Opportunities for Foreign Investment Indonesia’s Reliance On Imported Medical Devices Indonesia’s medical device industry was worth US$4.5 billion in 2019 with the majority (US$2.8 billion) coming from imported medical devices like diagnostic tools and medical lasers. On the contrary, the export of the same plunged to US$267 million. Following are some of the factors expected to further stimulate the demand for importing medical devices in Indonesia: Expansion of private and government hospitals and clinics Enhancements to the existing medical facilities Use of diagnosing devices for the rise in non-communicable diseases Liberalizing of government regulations Seamless process of importing medical devices for foreign manufacturers. Furthermore, Indonesia is a signatory to the ASEAN Medical Device Directive (AMDD), aimed at harmonizing rules across the region. Increased Demand Of Medical Devices Due to Covid-19 Due to the Covid-19 pandemic, Indonesia has set aside IDR 695.2 trillion towards funding its national economic recovery program. As a result, the number of imports of medical devices is set to rise. Moreover, in order to prevent the Covid-19 outbreak, the government has lifted numerous import restrictions on medical devices and is committed to simplifying the process of importing medical devices for foreign manufacturers. The culmination of all these factors presents a profitable window for foreign investors to set their footprint in the growing medical device industry. However, one needs to be aware of prerequisites and procedures for medical device registration in Indonesia. Indonesia Medical Device Registration – A Step-by-Step Guide Indonesia Medical Device Classification In Indonesia, medical devices are classified based on the risk level. The basis for the classification system is the ASEAN Medical Device Directive. Refer to the table below for classification: Class Category Risk Level Examples Level of Control I A Low Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale General Control II B C Low – Moderate Moderate-High Pregnancy self-testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask Blood glucose self-testing, ECG, Xray Unit, Syringe, Condom, Contact lens Special Control III D High HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker Pre Market Approval Process and Requirements of Medical Device Registration in Indonesia Obtain License from Indonesian Ministry of Health In order to import medical devices, a company has to obtain the distribution license called Izin Penyalur Alat Kesehatan (IPAK) issued by the MOH RI (Ministry of the Health Republic of Indonesia). One can file to MOH RI via an e-registration online system which makes the process simple and efficient. Following are the required documents one needs to keep handy in order to get a medical device registered by MOH RI: Executive Summary with a brief on marketing history, Intended uses and indications, regulatory clearances and pending approvals in other countries, and important safety or performance information Essential Principles Checklist Declaration of Conformity Device Description Design Verification and Validation Device Labeling Risk Analysis Manufacturer Information Requirements for Label, IFU (Instruction For Use), Brochure/Leaflet, and Manual Book of a Medical Device: Labeling of the product packaging Enclosed the figure, Product name, Manufacturer name & address Registration no, Batch No /Lot No, Warning with Symbol/logo, Indonesian or English language Manual book and IFU should be provided in original language and Indonesian language Brochure/leaflet with Indonesian and/or English language. Special Requirements HIV Products Should be tested at the Indonesia Reference National Laboratory Hospital (RSCM) Menstrual Pads and Adult Diapers, Condom, syringe Should have fluorescence tested at the Indonesia National Laboratory (Sucofindo, The Food and Drug Monitoring Agency/BPOM) For the product contains animal origin as its raw material (ex: catgut) Should have a certificate of free from disease and the product country of origin For the product radiation (ex: X-ray unit) Should have safety radiation certificate from National Nuclear Agency Open Software Software Validation report From Manufacture or independent laboratories Timeframe For Registration The time required to get a medical device registration has been listed below in accordance with the classification of the devices: Class A Medical Device or IVD Device: 15 Days Class B Medical Device or IVD Device: 30 Days Class C Medical Device or IVD Device: 30 Days Class D Medical Device or IVD Device: 45 Days Indonesia Medical Device Registration – Is Halal Certification required? In the future, Indonesia’s Government Regulation No. 31/2019 will require various types of items to be halal certified, as well as the labeling of products made from haram (non-halal) materials. Halal certification will be voluntary starting in 2021, although it will not be required for medical equipment until the following dates: Class A Medical Devices: 2026 Class B Medical Devices: 2029 Class C Medical Devices: 2034, Class D will be determined later by Presidential Regulation. Registering Your Medical Devices with Cekindo In Indonesia, only a medical device distributor company is authorized to register and distribute medical devices, hence posing a great challenge for a foreign investor to enter into the industry. However, Cekindo, with its comprehensive business solutions, helps you with the registration of your company and assists you in obtaining mandatory business and import licenses with minimum obstacles. Moving forward with the set-up of your company, Cekindo handles your hefty paperwork requirements for product registration and rules out delays. Our consultants can get your medical products Halal certified in a seamless way. Moreover, if a foreign investor wishes to import medical devices without establishing a company, Cekindo makes it possible by engaging with a local partner/distributor. To know more about how Cekindo’s solutions can help you make investments in Indonesia, please fill out the form below or talk to an expert on our chatbot. Read Full Bio Pandu Biasramadhan Senior Consulting Manager at InCorp Indonesia An expert for more than 10 years, Pandu Biasramadhan, has an extensive background in providing top-quality and comprehensive business solutions for enterprises in Indonesia and managing regional partnership channels across Southeast Asia.