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Thursday, September 23, 2021
Home » GMP: China Food and Drug Administration's (CFDA's) - GMP for Implantable Medical Devices

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

Certification TrainingProgram/Course ID: ELM-331
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 Implantable 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 issuing an Appendix of Implantable Medical Devices to Good Manufacturing Practices for Medical Devices, 2015 Number 102. These regulations are outlined in four parts 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 Appendix to GMPs for Implantable Medical Devices
Supplementary Provisions (Part 4)
Terminology (Part 3)
Part 1: Scope and Principles
Part 2: Introduction to Special Requirements

2.1 Personnel
Education and Training
Hygiene, Health, and Clothing Requirements

2.2 Workshops and Facilities
General Requirements
Acceptable Cleanliness Levels Part 1
Acceptable Cleanliness Levels Part 2
Clean Room Environment
Plumbing, Pest Control, and Other Environmental Requirements

2.3 Equipment
2.3 Equipment

2.4 Design and Development
2.4 Design and Development

2.5 Procurement
General Requirements
Implantable Animal-Derived Medical Devices
Implantable Allogenic Medical Devices

2.6 Manufacturing Management
General Requirements
Packaging and Storage
Animal-Derived and Allogenic Medical Devices
Cleaning, Disinfection, and Pest Control

2.7 Quality Control
2.7 Quality Control

2.8 Marketing
2.8 Marketing

2.9 Monitoring, Analysis, and Improvement of Adverse Events

Final Assessment


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.

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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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