Regulatory framework in ASEAN, China and Japan for devices and IVDs MCQs With Answer

Introduction: This quiz set covers the regulatory frameworks for medical devices and in vitro diagnostics (IVDs) across ASEAN, China and Japan — regions with active harmonization efforts and distinctive national requirements. Designed for M.Pharm students studying Regulatory Aspects of Medical Devices (MRA203T), the questions emphasize regulatory authorities, classification systems, registration dossier expectations, clinical evidence requirements, post-market obligations, and international harmonization initiatives (e.g., IMDRF/AMDD). These MCQs are aimed at building practical understanding for regulatory submissions, local representation, conformity assessment, and vigilance for devices and IVDs in these jurisdictions, giving you focused practice for exams and regulatory careers.

Q1. Which regional instrument aims to harmonize medical device regulation across ASEAN member states?

• Asia-Pacific Medical Device Compact
• ASEAN Medical Device Directive (AMDD)
• European Medical Device Regulation (EU MDR)
• North American Device Accord

Correct Answer: ASEAN Medical Device Directive (AMDD)

Q2. What is the primary national regulator for medical devices and IVDs in China?

• China Food and Drug Administration (CFDA)
• National Medical Products Administration (NMPA)
• State Drug Control Commission (SDCC)
• Ministry of Health and Family Welfare (MoHFW)

Correct Answer: National Medical Products Administration (NMPA)

Q3. Which Japanese organization is responsible for scientific review of medical devices before marketing authorization?

• Japan Device Registration Authority (JDRA)
• Ministry of Health, Labour and Welfare (MHLW) Review Division
• Pharmaceuticals and Medical Devices Agency (PMDA)
• Japanese Medical Device Council (JMDC)

Correct Answer: Pharmaceuticals and Medical Devices Agency (PMDA)

Q4. Which risk-based device classification scheme is commonly used in ASEAN, China and Japan?

• A two-tier system: Approved / Unapproved
• A risk-based four-class system: Class I, II, III, IV
• Hazard-only classification: Chemical / Non-chemical
• Device-only vs IVD-only binary split

Correct Answer: A risk-based four-class system: Class I, II, III, IV

Q5. In China, which device class is subject to the most stringent pre-market review and typically requires the most clinical evidence?

• Class I
• Class II
• Class III
• Class IV

Correct Answer: Class III

Q6. How are in vitro diagnostics (IVDs) classified in China for regulatory purposes?

• Not regulated as medical devices
• Risk-based classes I, II and III specific to IVDs
• Single unified category treated as consumer kits
• Only by manufacturing country approval

Correct Answer: Risk-based classes I, II and III specific to IVDs

Q7. Which one of the following is typically required in a device registration dossier across ASEAN, China and Japan?

• Marketing plan and projected sales volume only
• Clinical evidence or clinical evaluation demonstrating safety and performance
• Only a marketing authorization from any third country
• ISO 9001 certificate (without technical documentation)

Correct Answer: Clinical evidence or clinical evaluation demonstrating safety and performance

Q8. Which international standard for quality management systems is most commonly accepted by regulators for medical device manufacturers?

• ISO 9000
• ISO 14001
• ISO 13485
• ISO 27001

Correct Answer: ISO 13485

Q9. In Japan, the entity legally responsible for maintaining the device on the market and performing post-market obligations is called:

• Market Distribution Agent (MDA)
• Marketing Authorization Holder (MAH)
• Device Import Representative (DIR)
• Certified Conformity Assessor (CCA)

Correct Answer: Marketing Authorization Holder (MAH)

Q10. For an overseas manufacturer seeking to register a medical device in China, which local requirement is essential?

• Setting up a manufacturing plant in China
• Appointment of a local Chinese registration agent or local legal representative
• Obtaining EU CE Mark before China filing
• Registering with ASEAN first

Correct Answer: Appointment of a local Chinese registration agent or local legal representative

Q11. The ASEAN harmonization effort for medical devices is coordinated under which ASEAN mechanism or working group?

• ASEAN Investment Facilitation Taskforce
• ASEAN Consultative Committee for Standards and Quality (ACCSQ) — Medical Devices Working Group
• ASEAN Economic Ministers’ Health Subcommittee
• ASEAN Clinical Trials Alliance

Correct Answer: ASEAN Consultative Committee for Standards and Quality (ACCSQ) — Medical Devices Working Group

Q12. What does UDI stand for and why is it introduced by regulators such as China and Japan?

• Universal Device Index — to rank manufacturers
• Unique Device Identification — to improve traceability and post-market surveillance
• Unified Device Instruction — to harmonize IFUs across markets
• United Device Inspection — to combine inspection activities

Correct Answer: Unique Device Identification — to improve traceability and post-market surveillance

Q13. Which international forum has strongly influenced harmonization of medical device regulation and guidance used by ASEAN, China and Japan?

• World Health Organization (WHO) Diagnostics Network
• International Medical Device Regulators Forum (IMDRF)
• Global Drug Regulatory Council (GDRC)
• International Organization for Standardization Medical Group (ISO-MG)

Correct Answer: International Medical Device Regulators Forum (IMDRF)

Q14. For registration of imported medical devices in China, which document from the country of origin is commonly requested?

• Local environmental audit report
• Free Sale Certificate (FSC) or equivalent export documentation
• Local hospital adoption certificate
• Import tariff classification letter

Correct Answer: Free Sale Certificate (FSC) or equivalent export documentation

Q15. Which post-market system is a common regulatory expectation across Japan, China and ASEAN countries?

• Annual mandatory clinical trials for all devices
• Adverse event reporting and vigilance system for marketed devices
• No surveillance after initial registration
• Only manufacturer-held sales reports without regulator notification

Correct Answer: Adverse event reporting and vigilance system for marketed devices

Q16. Which dossier element refers to risk management documentation required by regulators (e.g., ISO 14971) for device approval?

• Label artwork files
• Risk analysis and risk management file
• Commercial competitor analysis
• Clinical site contracts

Correct Answer: Risk analysis and risk management file

Q17. The term CMC often appears in regulatory submissions. What does CMC stand for in the context of device/IVD submissions?

• Clinical, Manufacturing and Claims
• Chemistry, Manufacturing and Controls
• Compliance, Marketing and Certification
• Country, Manufacturer and Customs

Correct Answer: Chemistry, Manufacturing and Controls

Q18. In Japan, which ministry grants the final marketing authorization after PMDA review?

• Ministry of Economy, Trade and Industry (METI)
• Ministry of Health, Labour and Welfare (MHLW)
• Ministry of Internal Affairs and Communications (MIC)
• Ministry of Education, Culture, Sports, Science and Technology (MEXT)

Correct Answer: Ministry of Health, Labour and Welfare (MHLW)

Q19. Which of the following is a typical requirement for IVD registration in many ASEAN member states and in China and Japan?

• Proof of CE mark only, with no local documentation
• Demonstration of analytical and clinical performance appropriate to intended use
• Only manufacturing address is required
• Retail price approval certificate

Correct Answer: Demonstration of analytical and clinical performance appropriate to intended use

Q20. What was the previous name of China’s National Medical Products Administration (NMPA), commonly referenced in older regulatory documents?

• China Drug Authority (CDA)
• China Food and Drug Administration (CFDA)
• State Medical Equipment Bureau (SMEB)
• National Health Product Agency (NHPA)

Correct Answer: China Food and Drug Administration (CFDA)

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