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Home » GMP: China Food and Drug Administration's (CFDA's) - GMP for Medical Devices

GMP: China Food and Drug Administration's (CFDA's) - GMP for Medical Devices

Certification TrainingProgram/Course ID: ELM-330
Enrollment Period: 3 months.
Allocated Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: Good Manufacturing Practice (cGMP).
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Training Program: GMP: China Food and Drug Administration's (CFDA's) - GMP for Medical Devices
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsThis course focuses on providing an understanding of the Chinese Food and Drug Administration's (CFDA's) Announcement on Good Manufacturing Practices for Releasing Medical Devices, 2014 Number 64. These regulations are outlined in 13 Chapters (including 84 separate articles), which will be covered in this course. The purpose of this course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of medical devices as specified by the CFDA.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.

Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.


Who Should Take This Course?
Learning Objectives
Introduction to CFDA GMPs for Medical Devices
Supplementary Provisions (Chapter 13, Articles 79 - 84)

Chapter 1: General Provisions (Articles 1 - 4)
General Provisions (Articles 1 - 4)

Chapter 2: Institution and Personnel (Articles 5 - 11)
Institutional and Executive Management Responsibilities
Department Management Responsibilities

Chapter 3: Buildings and Facilities (Articles 12 - 18)
Facility Layout and Design
Environmental Conditions and Pest Control
Warehousing, Storage, and Inspection

Chapter 4: Equipment (Articles 19 - 23)
Equipment: Intended Use and Operating Procedures
Inspection and Calibration

Chapter 5: Document Management (Articles 24 - 27)
Quality Management System Documents
Document Control Procedures
Record Control Procedures

Chapter 6: Design and Development (Articles 28 - 38)
Design Control Procedures
Design and Development Input
Design and Development Output
Change Management and Risk Control

Chapter 7: Procurement (Articles 39 - 44)
Procurement Control
Suppliers and Procurement Requirements

Chapter 8: Manufacturing Management (Articles 45 - 55)
Manufacturing Procedures and Quality Control
Cleaning and Environmental Monitoring
Manufacturing Records
Inspection, Labeling, Traceability, and Product Protection

Chapter 9: Quality Control (Articles 56 - 61)
Inspection Instruments and Equipment
Product Inspection and Release Procedures

Chapter 10: Sales and After-Sales Service (Articles 62 - 66)
Chapter 11: Control of Nonconforming Products (Articles 67 - 70)

Chapter 12: Adverse Events Monitoring, Analysis, and Improvement (Articles 71 - 78)


Skill Level:

This training program has been developed to train employees with Intermediate Knowledge of China CFDA - GMPs.

Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

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