IV. Regulatory Compliance & Market Access Blueprint

The regulatory landscape in Southeast Asia is extremely diverse. Jianpei Technology needs to address the key barriers in each core market targeted.

4.1 Singapore Regulatory System (HSA GL7 Standard)

Singapore's regulatory framework is the "Gold Standard" for the region. Jianpei's AI-SaMD (Software as a Medical Device) products must comply with several laws:

Category	Specific Regulation
Medical Device Regulation	HSA Medical Device Registration Requirements
Data Privacy	PDPA (Personal Data Protection Act)
Biomedical Research	Human Biomedical Research Act
AI-specific Guidelines	GL7 Guidelines

GL7 Requirements for Adaptive Algorithms

Core Requirement

HSA's GL7 guidelines require manufacturers to follow a strict set of principles when implementing adaptive or continuous learning algorithms.

Jianpei must prepare:

1. Detailed documentation of its Algorithm Change Protocols (ACP).
2. Clear procedures for model retraining and deployment updates.
3. Ensuring safety and effectiveness are maintained throughout the lifecycle.

Strategic Advantage

By completing registration at the highest standard in Singapore, Jianpei will pave the way for approvals in other markets. Furthermore, proactively using the AI Verify testing framework by IMDA and PDPC can:

• Increase transparency as an assessment entity.
• Demonstrate the trustworthiness of the AI system.

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4.2 Indonesia Market Access: Addressing TKDN

The TKDN (Tingkat Komponen Dalam Negeri, Local Content Requirement) in Indonesia is the most critical barrier for entering the public procurement market.

Critical Alert

This is not merely an incentive but a strict market access prerequisite for organizations seeking meaningful market participation in Indonesia's massive economy.

4.2.1 Execution Strategy for TKDN Compliance

Jianpei Technology must make TKDN compliance a core objective of Phase II:

Strategy	Specific Action	Role
Local Entity & Capital Commitment	Establish a PT PMA with a 10 billion IDR investment (approx. 1M SGD)	Demonstrates long-term commitment to the local market
Localized R&D & Assembly	Keep product localization, data processing, UI customization, and equipment assembly in Indonesia	Increases local contribution rate
Local Co-creation Path	Partner with local research institutes and hospitals for clinical data collection and model training	Counts toward the local R&D component of TKDN

Case Study

The local NIVA (Non-Invasive Vascular Analyzer) technology, which took ten years of R&D to receive a marketing license, is a prime example of successful local co-creation.

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4.3 Key Market Regulatory Comparison & Strategic Focus

The varying regulatory focus across markets further validates the effectiveness of the Hub-and-Spoke Model.

Core SEA Market Regulatory & Strategic Focus

Market	Strategic Function	Primary Regulator	AI-SaMD Framework	Critical Barrier	Jianpei's Strategic Focus
Singapore	Governance & R&D Hub	HSA	GL7, AI Verify	Data Privacy (PDPA)	Pursue highest technical compliance; build regional credibility
Indonesia	Scale & Localization Spoke	Kemenkes	General MedDevice Regs, TKDN	TKDN, 10B IDR Min Investment	Local production coop, public procurement access, JKN integration
Malaysia	First Overseas Benchmark	MDA	Class B/C Device Regs	Local rep requirement, Malay UI, PDPA compliance	Sabah hospital PoC, full "Dr. Wood" deployment, replicable model validation
Thailand	Initial Commercial Launch	Thai FDA	Standard Device Classification	Mandatory ICR Appointment	Rapid ICR appointment; complete standard registration

Model Validation

Using Singapore's compliance as a technical high point and Indonesia's economic requirements as a localization focus—this dual-track strategy is an effective way to manage regional complexity.

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Change History

Version	Date	Description	Author
1.0	2025-12-16	Initial Version	Gemini
1.1	2025-12-16	Added Malaysia MDA requirements; updated Strategic Focus table.	Gemini