Quasi Medicine Registration
Indonesia has introduced a new regulatory category for quasi-medical products, which bridges the gap between consumer goods and medicinal products. Our quasi medicine registration service supports international manufacturers in classifying, registering, and legally marketing quasi medicine products in Indonesia in line with the latest BPOM regulatory framework.
Seamless Compliance Support
End-to-End Service
We manage the full regulatory pathway from licensing to product registration.
Regulatory Expertise
Our team combines deep knowledge and experience to navigate complex regulatory landscapes.
Speed and Efficiency
Our proven strategies accelerate the registration and approval process for the Indonesian market.
Customized Support
Provide personalized guidance and dedicated support to ensure a smooth, worry-free journey.
Why Choose Our Quasi Medicine Registration?
Indonesia’s Food and Drug Authority (BPOM) has introduced stricter supervision for traditional medicines, quasi medicines, and health supplements, redefining how certain products must be classified and registered. Products that were previously classified as cosmetics or consumer goods may now be categorized as quasi-medicines, triggering new regulatory obligations.
Our service helps international manufacturers navigate this evolving framework by providing clear regulatory positioning, documentation strategy, and BPOM submission support. We reduce the risk of misclassification, enforcement action, or forced product withdrawal by ensuring your product is registered under the correct category from the start.
This service is especially critical for products with:
- Functional or preventive claims
- Pharmacological or bioactive ingredients
- Borderline positioning between cosmetics, supplements, and medicines
Scope and Benefits of Our Service
Structured quasi-drug registration in Indonesia supports compliant market entry.
We support the setup and approval of licensed medical device distributors in compliance with MoH requirements.
Preparation of technical documentation, labeling review, and structured BPOM submission for quasi-drug products.
Coordination with BPOM during evaluation, clarification handling, and approval monitoring to reduce delays.
Market Entry Support
Flexible market entry options supporting IVD and medical product registration for international manufacturers entering Indonesia.
License Holder Service
For manufacturers without a local entity, we act as a neutral license holder, keeping registrations secure and transferable.
Distributor Selection
We assist in identifying and assessing qualified local distributors aligned with regulatory and commercial requirements.
Undername Service
We enable faster market entry by registering products under an approved local structure without immediate company setup.
Company Registration Support
When you are ready to establish a local presence, we assist with compliant company formation in Indonesia.
License Holder Service
For manufacturers without a local entity, we act as a neutral license holder, keeping registrations secure and transferable.
Distributor Selection
We assist in identifying and assessing qualified local distributors aligned with regulatory and commercial requirements.
Undername Service
We enable faster market entry by registering products under an approved local structure without immediate company setup.
Company Registration Support
When you are ready to establish a local presence, we assist with compliant company formation in Indonesia.
Inquiry Form
Our team is prepared to discuss your business needs and address any questions you may have. Fill out our inquiry form, and we’ll respond within one business day.
Other ways to get in touch with us.
- info@productregistrationindonesia.com
- +6221 5086 5603
- +62813 8543 0755
- Mon-Fri 9:00AM - 5:00PM
Frequently Asked Questions (FAQ)
What is a quasi-medicine product in Indonesia?
Why did Indonesia introduce stricter rules for quasi-medicines?
Do foreign manufacturers need to register quasi-drug products before import?
What types of products are commonly classified as quasi-medicines?
How is quasi-medicine different from cosmetics or supplements?
What documents are required for quasi-medical registration?
Can BPOM reclassify my product during evaluation?
Yes. BPOM may reclassify a product if it determines that claims or ingredients fall outside the initially proposed category.
We help manage this risk through early regulatory assessment and positioning strategy.
Can Product Registration Indonesia support reformulation or claim adjustment if required?
Why should international manufacturers work with Product Registration Indonesia for quasi-medical registration?
Strategic Leadership with
Dr. Hussein H. Mashhour, MD
As our Chief Operating Officer (COO), Dr. Hussein H. Mashhour, MD, brings over a decade of dedicated, hands-on experience in product registration and licensing across Indonesia’s most complex regulatory sectors. His strategic oversight ensures that our operational procedures and client services are built on proven, efficient processes. Start your journey with the confidence and clarity only an expert leader in both compliance and operations can provide.
