eLearning: MyCompliance

for regulatory affairs of medical device (IVD)

Keyword

Medical Device, in vitro diagnostic, State Council Ordinance, China Food and Drug Administration, National Medical Products Administration, NMPA, regulatory affairs, technical document, risk management, verification and validation, RPS, UDI, change registration, marketing authorization holder, overseas manufacturer, overseas factory inspection, outsourced manufacturing, type testing, product technical requirement, usability validation, clinical evaluation, instruction for use, labels, adverse event, vigilance, Quality management system, 医疗器械, 指导原则, 质量抽查, 说明书和标签, 体外诊断试剂, in vitro diagnostics, MDR, FDA, MDSAP, Taiwan, eSTAR, conformity assessment, ANVISA, Kaizen, global registration, regulatory intelligence, webinar, online university, template, on-demand workshop

Another definitions s. Encyclopedia

Have you visited any education webinar, online certification program or used learning management system to learn regulatory affairs? One missing point is interactive coach.

With our eLearning "MyCompliance" for regulatory affairs of medical device you have your own coach all the time, case - or real field study and personal meeting.

Session 1: Chinese access of medical device

In this session you will learn the basic knowledge of Chinese registration of medical device and IVD.

1.0 Roadmap of Chinese registration

1.1 Chinese authority: NMPA

1.2 Chinese agent

1.3 Chinese certificate

1.4 Type of registration

1.5 Classification and product code

1.6 Time and cost

*new:

Knowing Chinese regulation by yourself

Session 2: Registration in China

In this session we will dig deeper to important steps prior to and during the Chinese registration of medical device and IVD.

2.1 Type Testing

2.2 Product technical requirement

2.3 Technical documentation

2.4 Clinical study and clinical trial

2.5 Chinese labelling

Session 3: Chinese Post market and quality management

After product approval by authority you should know the post market and quality management activities in Chinese market.

3.0 Post market surveillance

3.1 Chinese vigilance system

3.2 Significant change

3.3 Periodic Risk Evaluation Report

*new:

Overseas inspection

Outsourced production

Session 4: Global markets of medical device

We will gain some global impression how the registration of medical device and IVD in other markets look like.

4.0 Global registration

4.1 From MDR in Europe to NMPA in China

*new:

Quality management renewal

Change registration

International vigilance

From MDR to FDA

From FDA to NMPA

Session 5: Regulatory Affairs Soft Skills

The soft skills of regulatory affairs is the key besides regulatory know how.

5.1 Regulatory affairs soft skills

5.2 Kaizen in regulatory business

*new:

Projectmanagement

Communication skills