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E-Learning of Regulatory Affairs (Chinese registration and beyond)

Welcome to

E-learning of Chinese and global Compliance of medical device

Unique feature of E-learning

Free one to one supervisor with regular on demand meeting
Test and homework with professional personal examination and feedback
Possible expert opinion for current registration and other strategy
Update of new Chinese registration, videos and templates

Session 1: Chinese access
Session 2: Registration in China
Session 3: Chinese Post market and quality management
Session 4: Global markets
Session 5: Regulatory Affairs Soft Skills

E-Learning can be visited any time, valid for 1 year.

Participation possible any time, 24 hours a day, 7 days a week

Testimonials

W.M

I was searching job from academy and visited the basic E-Learning. It is great to have an overview of regulatory work. I finally get a job.
M.Z

After encountering an article I joined one year MyCompliance. I realize that the regulatory affairs in China can be so grateful spoken out. I am confident in global registration project.

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G. K

I really like interactive part of soft skills. After knowing ingenious Kaizen in regulatory life I have loved my career and try to improve my skills daily.

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Prof J N

For my small group I booked the E-Leaning. Surprised the organise cut personised sessions and add wished international market. I see the enthusiasm of my colleague after visiting the courses. Even we meet in group personally in Swiss. It was great active meet up better than any one hour webinar hunting every topic in short slide every 3 minutes. Merci.

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Keyword

Medical Device, in vitro diagnostic, State Council Ordinance, China Food and Drug Administration National Medical Products Administration, NMPA, technical document, risk management, verification and validation, RPS, UDI, change registration, marketing authorization holder , overseas manufacturer, outsourced manufacturing , type testing, product technical requirement, 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, conformity assessment, ANVISA, Kaizen, global registration, regulatory intelligence, webinar, online university, template, on-demand workshop, roadmap, interim regulatory affairs, project management, product management, international product launch, ventre capital

Learning audience

Student and unemployed:

Basic knowledge for Chinese registration

Non Medtech personal:

Gain overview and tactic of Chinese market entry, useful for publication (medical writers)

Non Regulatory personal:

Perfect for career changer

Regulatory professionals:

Either with or without experience of Chinese registration, improve registration efficiency, ideal as boot camp for RA group

Leaning objective

Regulatory Affairs (registration) of medical device and IVD in China and beyond

Technical documentation in Chinese requirement

Start from EU and US to Chinese dossier

Quality management, quality assurance, project management, labelling, production, post market in term of Chinese registration

Intelligent Leverage of international registration

Soft skills of international regulatory affairs

Proof of E-learning

A certificate will be issued after successful test for each session and qualitative homework.

Example of one session in E-learning

In each session it is made of learning article, videos and test. Depending on your demand, you can ask for a supervisor minutes.

Open Videos to share knowledge

We try to share open sources of valuable video explaining the keys of Chinese and global regulation. The professionel version is coming up. Register as soon as possible because the early bird has cost benift and possibility to book trainer online.

Start: Participation possible any time.

Duration: 1 year

How to start: Kick off meeting with trainer, book training

End of E-Learning: for professional user there is test, free supervision hours and certificate

1. Insight of essential webistes with regulation of medical device and IVD

The following video share important Chinese websites where you can explore the different topics. Try to bookmark the links to monitor the useful contents using English translation.

2. In-country representative (Chinese agent)

Do you know that you need an in-country representative in China to register your medical device or IVD? It has also a smart name "Chinese agent". It is similar to "US agent" and plays a greater role than authorised representative in EU preparing, submitting dossier, replying deficiency and assissting post market to authority. It has little to do with importer and distributor.

Watch the video and be clear finally with your Chinese partner.

Read how to find Chinese partner

3. Chinese certificate of medical device and IVD

The Chinese certificate covers the basic info as legal manufacturer, name of product, Chinese agent and certification number etc. The characteristic parts of Chinese Identity document (ID) of medical device and IVD are performance specifications at PTR. Altogether it acts as “Chinese ID” or “visit card” in Chinese commercialization after product approval.

Payment

It is payed at the beginning of eLearning, valid for 1 year.

Cancellation is possible in 14 days free and with refund of 80% course payment (minus 20%) in 2 months. The cancellation is not valid if more than 2 sessions in professional compliance module was completed or template was sent to client already.

The enrolment of course could be transferred to second person upon our approval.

Early bird cost: 19 % discount

Standard MyCompliance

999 EUR

· + 40 topics

· + 20 Videos

· Multi choices Test

· 90 Min free consulting (one to one)

Professional Mycompliance

1499 EUR

· + 40 topics

· + 20 Videos (Update)

· + 20 case study Assessment

· Multi choices Test

· Update of new Chinese regulation

· Free template + 10

· 200 Min free consulting (one to one)

Enrolment of E-learning

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Chinese GMP guidance of medical device

18 October 2024

Chinese GMP is equivalent to ISO 13485 but with Chinese accent of factory, PTR, quality control and outsouced critical process.

Trace Chinese Registration

11 September 2024

Either for regulatory affairs (registration) in China or beyond, if you have a solid Excel or Word file with tracing items (e.g. PTR), have a free meeting with us. We will make a GRTIS matrix in customer project. You decide the next step and success at Chinese registration