Regulations & Know-how

CIRS will perform as your local representative and work with you to design and implement a competitive and cost-efficient regulatory strategy for your medical devices registration and market access in China.

The table below is a list of China Medical Device regulations we can help you comply with. The legislation covers medical devices Classification, Labeling and Packaging, Testing, Registration, Clinical Trial, Quality Assurance, Manufacture and Distribution, Advertisement, Post-market Monitoring, Customs Clearance, IPR Protection, etc. Most of these regulations have been or will be revised soon by Chinese government over these years to overhaul the medical devices management in China.

Services by Regulations

Sector	Regulations (Click each item for more information)
Overview	Overview of Medical Device Management Policies in China Decree No. 650 - The Regulations for the Supervision and Administration of Medical Devices
Classification & Nomenclature	What Is The Classification of Medical Devices How to Classify Your Medical Devices Name Your Medical Devices
Labeling & Packaging	Introduction to Medical Device Labeling and Packaging General Medical Device Labeling and Packaging Requirements In Vitro Diagnostic Reagent Labeling Requirements
Product Testing	What Is The Product Testing for Pre-assessment for Medical Device Technical Requirements Rights and Obligations of Medical Device Testing Institute The Qualification Determination for Medical Device Testing Institute
Registration	How to Record/Register Your Medical Devices Record Keeping for Class Ⅰ Medical Devices Registration for Class Ⅱ & Ⅲ Medical Devices Registration for In Vitro Diagnostic Reagents The Guideline on Preparation of Medical Device Technical Requirements Special Review and Approval Procedure for Innovative Medical Devices Preparation of Medical Device Technical Requirements
Clinical Trial (GCP)	Introduction to Technical Guiding Principle on Medical Devices Clinical Evaluation Clinical trial approval for Class III medical device with higher risk Whether your product can exempt from clinical trials How to design the clinical trial for In vitro diagnostic reagent? The Quality Management Practices for Medical Device Clinical Trial (SFDA notice No. 68 2012)
Quality Assurance (GMP, GSP)	The Quality Management Practices for Medical Device Manufacturing (CFDA notice No. 64 2014) The Quality Management Practices for Medical Device Distributing (CFDA notice No. 58 2013) The Quality Management Practices for Medical Device Use (CFDA notice No.51 2014)
Manufacture & Distribution	Administrative Measures for the Supervision of Medical Device Manufacturing(CFDA Order No. 7 2014) Administrative Measures for the Supervision of distribution of Medical Devices(CFDA Order No. 8 2014) The Measures for the Supervision and Administration of Internet Food and Drug Distributing (Draft for comments-2014) The Provisions on Notification of Class I Medical Device Manufacturing and Class II Medical Device Distributing (CFDA Notice No.25 2014) The Management Provisions for Medical Device Manufacturing Enterprise Classification (CFDA notice No.35 2014)
Advertisement	The Examination Measures for Medical Device Advertisement (MOH Order No. 65 2009) The Evaluation and Publication Standard for Medical Device Advertisement (MOH Order No. 40 2009)
Post-market Monitoring	The Provisions for Medical Device Recall (interim MOH order No. 82 2011) The Procedural Provisions on Administrative Punishment for Food and Drug (CFDA Order No. 3 2014) The Guide for Medical Device Adverse Event Monitoring (interim SFDA notice No.425 2011) The Requirements for Medical Device Adverse Event Monitoring and Re-evaluation (interim 2009)
Customs Clearance	The Management Measures for Imported Medical Device Inspection and Supervision (AQSIQ Order No. 95 2007)
IPR Protection (Patent, Trademark, Copyright)	The Trademark Law of the People’s Republic of China (2013 Revision) The Implementing Regulations of the Trademark Law of the People's Republic of China (2014 Revision) The Patent Law of the People’s Republic of China (2008 Revision) The Implementing Regulations of the Patent Law of the People’s Republic of China (2010 Revision) The Copyright Law of the People’s Republic of China The Implementing Regulations of the Copyright Law of the People’s Republic of China The Regulations of the People's Republic of China on Customs Protection of Intellectual Property Rights (State Decree No.395 2004)