Medical Device Registration in Indonesia – Updated Regulation

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. Learn more about medical device registration in Indonesia.

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.

READ MORE:

• SNI License and Product Registration in Indonesia
• Product Registration in Indonesia: How to Register Products via BPOM
• Health & Food Supplement Registration: What You Need to Prepare

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	RiskLevel	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	BC	Low –ModerateModerate-High	Pregnancy self-testing, Electric Hospital Bed, Surgical Lamp, Surgical MaskBlood 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 for Medical Device Registration

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

Product Classification

In Indonesia, the categorization of medical devices generally follows the Global Harmonization Task Force (GHTF) standards and adopts the ASEAN Medical Devices Directive framework. Devices are grouped into four levels based on risk:

• Class A: Low risk
• Class B: Low to medium risk
• Class C: Medium to high risk
• Class D: High risk

The registration process varies according to the risk class of the device. To streamline this, Asia Actual provides a regulatory system called R.O.S.E., which helps regulatory specialists find comparable devices (predicate devices) and determine their proper classification.

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 InCorp Indonesia

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, InCorp, 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, InCorp 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, InCorp makes it possible by engaging with a local partner/distributor.

To know more about how InCorp’s solutions can help you make investments in Indonesia, please fill out the form below or talk to an expert on our chatbot.

Frequently Asked Questions