The Ministry of Health, also referred to as Departemen Kesehatan, is the governmental entity responsible for executing health policies. It is headed by the Minister of Health, who reports directly to the Indonesian President. The National Agency of Drug and Food Control (BPOM), functioning under the MoH, oversees the registration of medical devices and pharmaceuticals in Indonesia.
2. Indonesia’s National Agency of Drug and Food Control Medical Device Registration
Every medical device, whether produced within Indonesia or imported, must undergo registration using the Online Medical Device Registration platform.
In Indonesia, the classification of medical devices aligns closely with the guidelines of the Global Harmonization Task Force (GHTF) and is being synchronized in accordance with the ASEAN Medical Devices Directive. The classification consists of four classes—A, B, C, and D – arranged in ascending order of risk. The device registration pathways vary depending on the classification assigned to the device.
International manufacturers looking to market their medical devices in the Indonesian market are required to designate a Local Representative. This representative is responsible for submitting the necessary documents for the registration process to the Directorate of General Pharmaceutical Service and Medical Device.
The Local Representative has to establish an account on the online portal. The registration procedure remains consistent across all device classes, but the documentation requirements differ based on the device classification. The registration comprises two stages — Pre-Registration Process and Evaluation Process.
The BPOM validates the device classification and determines the government fees. The outcome of the pre-registration, along with the invoice, is communicated to the applicant via email. The local representative is responsible for making the payment and uploading the proof of payment. The BPOM reviews the submitted documents and communicates the results to the applicant through email. In certain cases, specific devices need to implement in-country testing at an accredited laboratory.
The typical timeframe for registering new medical devices in Indonesia ranges from two to ten months.
3. Indonesia’s National Agency of Drug and Food Control Pharmaceutical Registration
Pharmaceutical products in Indonesia are categorized into four groups:
Controlled Substances: Narcotic drugs available exclusively through prescription, rigorously monitored by the Ministry of Health.
- Prescription Medications: Medications only accessible with a prescription
- Restricted Non-prescription Medications: Medications available to the public exclusively through authorized pharmacies
- Over-the-Counter Medications: Medications easily accessible to the public without a prescription
The pre-registration process aims to establish the appropriate review and evaluation pathway for the application. The BPOM assesses drug applications through one of three pathways (Path I, II, or III). Path I targets drug applications for products addressing serious or life-threatening diseases. Path II is appropriate for new drugs already approved in specific designated countries. Any drug applications for products not meeting the criteria for Path I or Path II evaluation processes undergo review via the Path III process.
The registration dossier should contain the following information:
- Administrative data and product information
- Quality summary and reports
- Non-clinical overview, summary, and study reports
- Clinical overview, summary, assessment reports, and study reports.
The head of the NA-DFC is responsible for issuing the marketing authorization approval/non-approval decision. Marketing authorization licenses are valid for five years in Indonesia. In certain cases, the BPOM may request additional data. In such cases, the applicant has 120 days to submit the requested information.
It takes about 150 to 300 working days for a drug to be approved in Indonesia, depending on the drug’s characteristics and its approval status in foreign countries.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.kemkes.go.id/eng/home