The healthcare sector in Indonesia has undergone significant growth and transformation in recent years. The country has made strides in improving access to healthcare, reducing maternal and child mortality rates, and combating infectious diseases.
In this article, we will explore the most important areas, trends, and systems in the healthcare sector in Indonesia.
Healthcare Infrastructure in Indonesia
Indonesia is the fourth most populous country in the world, with a population of over 270 million people. Despite the large population, the country has a shortage of healthcare professionals and facilities. According to the World Health Organization (WHO), there are only 0.2 physicians and 1.2 nurses per 1,000 people in Indonesia.
The government has made efforts to improve the healthcare infrastructure in the country. In 2019, the government launched the National Health Insurance program, which aims to provide universal healthcare coverage to all citizens by 2014. The program has already made a significant impact, with the number of Indonesians covered by health insurance increasing from 23% in 2014 to 91% in 2020.
Healthcare Trends in Indonesia
The healthcare sector in Indonesia is rapidly evolving, with several trends shaping the industry. One of the most significant trends is the increasing demand for digital healthcare services.
The COVID-19 pandemic has accelerated the adoption of telemedicine in Indonesia, with many patients turning to online consultations to avoid exposure to the virus. The government has also recognized the potential of telemedicine to improve access to healthcare in remote and underserved areas.
Another trend in the healthcare sector in Indonesia is the rise of medical tourism. The country has become a popular destination for medical tourists, particularly from neighboring countries such as Singapore and Malaysia. The government has recognized the potential of medical tourism to boost the economy and has made efforts to promote the sector.
In addition, there is a growing demand for specialized healthcare services in Indonesia. The country has a high prevalence of non-communicable diseases such as diabetes and cardiovascular disease. As a result, there is an increasing need for specialized facilities and services to manage these conditions.
Healthcare Systems in Indonesia
The healthcare system in Indonesia is a mix of public and private providers. The government provides healthcare services through a network of public hospitals and clinics.
Private providers also play a significant role in the healthcare sector, with many Indonesians opting for private healthcare services due to the perceived higher quality of care.
One of the challenges facing the healthcare system in Indonesia is the unequal distribution of healthcare resources. The majority of healthcare facilities and providers are concentrated in urban areas, leaving rural and remote areas underserved. This has resulted in disparities in health outcomes between different regions of the country.
The big challenge facing the healthcare system in Indonesia is also the shortage of healthcare professionals. The country has a limited number of doctors and nurses, and many healthcare professionals choose to work in urban areas rather than rural areas.
Another challenge is also e.g. the bureaucratic process regarding medical device registration in Indonesia and also other product registration in Indonesia. Medical device registration in Indonesia is a mandatory process that all medical device manufacturers must follow before they can market their products in the country.
The process of medical device registration in Indonesia is regulated by the National Agency of Drug and Food Control (NA-DFC) or Badan Pengawas Obat dan Makanan (BPOM). The regulatory framework is in accordance with the ASEAN Medical Device Directive (AMDD) and the Global Harmonization Task Force (GHTF).
The following are the steps involved in the medical device registration process in Indonesia:
1. Classification:
Medical devices in Indonesia are classified into four classes based on their risk level, with Class A being the lowest and Class D being the highest. The classification is based on the intended use, mode of action, and duration of contact with the body.
2. Pre-Market Approval:
Once the classification is determined, the medical device manufacturer needs to obtain pre-market approval from BPOM. This involves submitting a product registration application that includes technical data, labeling, instructions for use, and clinical data.
The application should also include the manufacturer’s quality management system (QMS) certification, which is mandatory for Class C and D devices.
3. Evaluation:
The BPOM evaluates the product registration application and may request additional information or clarification. The evaluation process may take up to 180 working days.
4. Post-Market Surveillance:
After the medical device is registered, the manufacturer must comply with post-market surveillance requirements. This includes monitoring the device’s performance, safety, and efficacy and reporting any adverse events or product recalls to the BPOM.
The following are the requirements for medical device registration in Indonesia:
1. Local Representation:
Foreign manufacturers must appoint a local representative in Indonesia who is responsible for submitting the product registration application and communicating with the BPOM.
2. Quality Management System (QMS) Certification:
Class C and D devices must have QMS certification from an authorized certification body. The QMS certification must be in accordance with the ISO 13485:2016 standard.
3. Technical Requirements:
The medical device must meet technical requirements specified in the Indonesian Medical Device Regulation, including safety, performance, and labeling requirements.
4. Clinical Data:
The product registration application must include clinical data that demonstrate the safety and efficacy of the medical device.
5. Labeling:
The medical device labeling must be in Indonesian and must include the device’s name, intended use, and precautions for use.
In summary, medical device registration in Indonesia is a complex process that requires manufacturers to comply with strict regulatory requirements. The process involves several steps, including classification, pre-market approval, evaluation, and post-market surveillance.
Manufacturers must also comply with requirements related to local representation, QMS certification, technical requirements, clinical data, and labeling.
Healthcare Statistics in Indonesia
According to data from the World Bank, Indonesia’s healthcare expenditure as a percentage of GDP was 2.9% in 2018. This is significantly lower than the global average of 9.9%.
However, the government has made efforts to increase healthcare spending in recent years, with healthcare expenditure increasing by 60% between 2014 and 2019.
The maternal mortality rate in Indonesia has also improved significantly in recent years. According to data from the World Health Organization, the maternal mortality rate in Indonesia decreased from 228 deaths per 100,000 live births in 1990 to 126 deaths per 100,000 live births in 2017.
In terms of infectious diseases, Indonesia has made significant progress in combating malaria. The country has reduced the incidence of malaria by 80% since 2000, and the number of malaria-related deaths has decreased by 90%.
