Introduction

Indonesia has established strict and comprehensive regulations governing health products, including those utilizing human-derived raw materials. Many companies have yet to fully comprehend that not all human-derived products can be registered as medical devices. This article will clarify the distinction in product classification and regulatory boundaries applicable in Indonesia.

Primary Regulation: Health Law Number 17 Of 2023

The Indonesian government has established an explicit prohibition regarding the commercialization of human organs and tissues through the Health Law Number 17 of 2023. This prohibition is not merely a regulatory limitation but an enforcement of humanitarian values and ethical principles in healthcare delivery.

Article 124 paragraph (3) of Health Law No. 17 of 2023 states:

"Organs and/or human tissues as referred to in paragraph (1) are prohibited from being commercialized or bought and sold for any reason whatsoever."

Additionally, Article 432 of the Health Law imposes severe criminal penalties for violators. Offenders may face imprisonment for up to 7 (seven) years and/or fines of up to Rp2,000,000,000 (two billion rupiah).

Critical Distinction: Medical Device Vs Drug/Biological Product

A common misconception in the industry is classifying human-derived products as medical devices. However, the definition of medical devices according to Health Minister Regulation Number 62 of 2017 is unambiguous:

"Medical Device is an instrument, apparatus, machine and/or implant that DOES NOT CONTAIN DRUG and is used for prevention, diagnosis, cure and relief of disease, care of the sick, restoration of health in humans, and/or formation of structure and restoration of body function."

This means that products containing major pharmacological components or derived from human materials cannot be classified as medical devices. Such products must be registered as drugs or biological products through BPOM.

Human-Derived Products Prohibited From Registration As Medical Devices

Based on Indonesian regulatory classification, several human blood derivative products cannot be registered as medical devices as they fall within the drug or biological product category:

Technical Reasons For The Prohibition

1. Primary Pharmacological Effect
   The products mentioned above (particularly Thrombin) work through pharmacological, immunological, or metabolic mechanisms. This clearly distinguishes them from medical devices which should work mechanically, physically, or through other means without primary pharmacological effects.
2. Human-Derived Source = Stringent Quality Control
   Human-derived products require tightly controlled supply chains, including donor laboratory screening, disease testing, and specific GMP (Good Manufacturing Practice) standards at plasma fractionation facilities. This complexity is consistent with drug/biological product regulations rather than medical device regulations.
3. Prevention of Commercial Abuse
   By positioning human-derived products as drugs (rather than medical devices), Indonesian regulation ensures stricter oversight and prevents potential abuse for commercial gain that would harm donors.

Exception: Non-Human Derived Products

It is important to note that not all biological products are prohibited from being classified as medical devices. Products derived from non-human sources may be registered as medical devices subject to specific requirements:

• Products derived from animals and their derivatives (non-living)
• Cells and tissues of microbial or recombinant origin
• Synthetic products engineered through biotechnology

Implications For Industry

For companies planning to develop or sell human-derived products in Indonesia, understanding regulatory classification is the critical first step. Misclassification can result in:

• Rejection of registration application by BPOM
• Revocation of marketing authorization (if already registered)
• Administrative and criminal penalties under Article 432 of the Health Law
• Damaged company reputation in the market

Conversely, this regulation also opens opportunities for domestic pharmaceutical industries to develop locally-derived plasma products, with government support through certified plasma fractionation facilities.

Conclusion

Indonesian regulations regarding human-derived products have been carefully designed to protect public safety, ensure ethical use of human biological materials, and prevent exploitation. Thrombin, albumin, clotting factors, and other plasma derivative products are drugs or biological products – not medical devices – and must follow the BPOM registration pathway with strict applicable standards.

For healthcare industry stakeholders, deep understanding of regulatory classification, the correct registration pathway, and technical requirements is the best investment to ensure your products circulate legally and safely in the Indonesian market.