Drugdu.com expert's response:

The difficulty in obtaining qualifications for Class II and III medical devices lies in high product risks, strict supervision, complex procedures, high professional thresholds, large investment, long cycles, and enterprises often being rejected repeatedly due to insufficient compliance capabilities, non-standard materials, or non-compliance with requirements for premises, personnel, and systems. 

I. Root Cause: Supervision Intensity Determined by Risk Level

II. Process & Approval Difficulty

1. Registration (Most Difficult)

2. Production License

Requires production license + registration certificate, approved by provincial medical products administrations.

Core: GMP system + production premises + equipment + personnel + records + traceability, with strict on-site inspections.

3. Operation License / Filing

Class II operation: Filing system, but requires premises, personnel, systems, and computer systems.

Class III operation: Licensed by municipal medical products administrations.

Requirements: warehouse ≥ 40–50 ㎡, temperature & humidity monitoring, cold chain, quality director (college degree in relevant major + 3 years of experience).

III. Hard Compliance Thresholds

1. Personnel Qualifications

Quality director / management representative:

Relevant majors (medicine, pharmacy, biology, chemistry) + education + work experience + social insurance, all mandatory.

Production / inspection / after-sales personnel: professional training and certification required.

2. Premises & Hardware

Operation: Commercial address, separated from living areas, warehouse area, temperature & humidity control, ventilation, fire protection, pest control, cold chain.

Production: Clean areas (by grade), purified water, sterilization, testing equipment, storage, retention samples, pollution prevention.

3. Quality Management System (GMP)

Documented system required: quality manual, procedures, SOPs, records, deviations, changes, CAPA, traceability, adverse events, recalls, etc.

Class III system inspections are stricter, more detailed, and more frequent.

4. Clinical & Verification

Class II: Clinical evaluation via equivalent products or clinical trials.

Class III: Mandatory clinical trials with very high requirements for ethics approval, trial design, sample size, statistics, and reports.

IV. Practical Pain Points for Enterprises

Complex and frequently updated policies: Numerous regulations, guidelines, and inconsistent local implementation, difficult for enterprises to keep up.

Shortage of professional talents: Few professionals proficient in regulations, systems, clinical trials, and registration; SMEs struggle to afford full-time compliance teams.

High error rate in materials: Over 40% of rejections due to non-standard, incomplete, or logically inconsistent documents.

High investment & long cycle: High costs for testing, clinical trials, premises, equipment, personnel, and system construction. Class III registration often costs millions and takes years.

Strict on-site inspections: Unannounced inspections, system audits, sampling inspections; failure in any step results in rejection.

V. Key Differences: Class III Is Harder Than Class II

Approval level: Class II (provincial); Class III (national).

Clinical requirements: Class II mostly exempt or equivalent evaluation; Class III mandatory clinical trials.

System inspection: Class III is stricter, more comprehensive, and more frequent.

Risk control: Class III requires stricter full life cycle management, traceability, adverse events, and recalls.

In Summary

The reason why Class II and III medical device qualifications are difficult to obtain is that supervision is responsible for life safety, and every step is designed to minimize risks.