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Dr. Fachrurrodji, Sp.PK

Dr. Fachrurrodji is a specialized clinical pathologist and Medical Device & IVD Expert Consultant bridging the gap between laboratory medicine and regulatory compliance. His expertise spans the full diagnostic lifecycle, from clinical validation and quality assurance to the interpretation of complex data in hematology and infectious diseases. By integrating hands-on pathology experience with rigorous regulatory knowledge, he advises on Class 3 Clinical Trials, ensuring that new diagnostic technologies meet strict safety and performance standards before widespread adoption.
Indonesia IVD Registration: How the Pathway Differs from a Medical Device
Radioactive IVD Registration in Indonesia: Inside the IVD Radiation Regulatory Pathway
Changing Your Company Address in Indonesia? Your IDAK Does Not Transfer: Here is Why It Matters
GMP & Cold Chain Compliance for Probiotic Health Supplement in Indonesia
Indonesia’s New Health Supplies Regulation (Permenkes No. 5/2026): A Complete Guide for Medical Devices, Pharma, Cosmetics & Supplements
Understanding the Fast-Track Medical Device Registration Process in Indonesia Through a Local Authorised Representative

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