Products & Services

Consulting

Pre-market China Product Regulations and Technical Path Consultation QMS(Quality Management System)China QMS Counselling China Medical Device Distribution QMS Counselling Training and Other Consulting Services China Domestic Agent Service for Imported Medical Devices Perennial Regulatory Consultant for Medical Devices in China

Entrusted R&D and production services

Medical Device R&D Support

Master Files Submission Master Files Submission of Raw Materials in China Master Files Submission of Pharmaceutical Excipients in China Master Files Submission of Pharmaceutical Packaging Materials in China Technical Support for R&D Safety Evaluation of Leachable Substances in China Technical Support for Product Pre-test and Rectification in China Risk Evaluation and Management

Medical Device Registration

Product Classification Product Classification Determination Request Medical Device Filing/Recording and Registration Class I Medical Device Filing/Recording Class II/III Medical Device Initial Registration Class II/III Medical Device Registration Change Technical Files Compilation Testing Product Testing Rectification Technical Support Other Services Medical Device Registration Under the MAH System Registration of Imported-to-domestic Products Follow-up and Correction of Medical Device Registration Technical Review

Clinical Evaluation & Clinical Trial

Clinical Evaluation (Non-trial Method)Clinical Evaluation Report for Products that are Exempt from Clinical Trials Clinical Evaluation Report for Adopting Clinical Trials or Clinical Application Data of the Same Variety Products Clinical Evaluation Report for Adopting Overseas Clinical Trials Data Clinical Evaluation Report for Adopting Real-world Data Clinical Trial Clinical Trial Documentation Preparation Clinical Trial Audit Clinical Trial Statistical Analysis Clinical Trial Data Management Implementation and Management of Clinical Research Projects

Pre-clinical Animal Experiment

Pre-clinical Animal Experiment

Medical Device Safety Evaluation and Testing

Chemical Characterization of Materials Chemical Characterization of Materials Safety Evaluation for Extractables & Leachable Substances Safety Evaluation for Extractables & Leachable Substances Biocompatibility Testing Biocompatibility Testing Microbiological Testing Microbiological Testing Validation of Cleaning,Disinfection, Sterilization Validation of Cleaning, Disinfection, Sterilization Restricted Substance Testing Restricted Substance Testing Cleaning Room Environment Validation and Process Water Testing Cleaning Room Environment Validation and Process Water Testing

Resources

Medical Device Regulatory Compass

Medical Device Classification Rules Medical Device Registration Routes Registration Testing Clinical Evaluation Raw Materials for Medical Device

Presentations & Recordings

Tools & Database

China Medical Device Regulation database Applicable Standards & Technical Requirements Database Qualified Testing Institutes in China

White Paper & eBook

News & Events

Regulatory News

Seminar on on the Development Trends and Registration Process for Cosmetic Medical Devices in China Policy Interpretation —— How to Enter the “Fast Track” of Priority Approval？Statistics on the Clinical Trial Data of Quantitative Detection Products of In Vitro Diagnostic Reagents What Data Should be Submitted to Prove the Hemostatic Mechanism of Absorbable Hemostatic Products in China?Announcement on Relevant Matters Concerning the Production of Imported Medical Devices by Enterprises in China On What Conditions Can Surgical Instruments Be Exempted From Biological Tests？Regulations on the Reference of Clinical Trial Data in China Is It Possible to Choose A Single-group Target Value Design for Clinical Trials of Intracranial Drug-coated Balloon Dilatation Catheters？What are the Requirements for Anticoagulants Used in Clinical Trials of In Vitro Diagnostic Reagents?About the Measurement Function in the Medical Device Software, What Issues Should be Concerned About in the Registration Application Data?Guideline on Market Access for Medical Device in China Precautions and Registration Preparations for Radio Frequency Beauty Products Transferred to Medical Devices Procedures for handling adverse events in clinical trials of medical devices Common Technical Issues of Active Medical Device 3 Common Technical Issues of Active Medical Device 2 Analysis of Flight Inspection on Unqualified Medical Devices Common Technical Issues of Active Medical Device Ligation clip (closed clip) registration case analysis The Essence of Newly Revised “Regulations on the Supervision and Administration of Medical Devices”What is the Medical Device Master File Registration System 【NMPA】Announcement on the Registration Items of the Master File of Medical Devices (No. 36 of 2021)Approved and Registered Medical Device overview in January 2021 【CMDE】Introduction of Medical Device Registration Process 【CMDE】Product Technical Requirements and Registration Testing 【CMDE】Medical Device Registration System 2020 Medical Device Registration Work Report Free Webinar: Overview of Chinese Medical Device Regulations 【Free Webinar】Overview of Chinese Medical Device Regulations - Korea Branch Registration Application of Software Medical Device Free Webinar: Overview and Update of Medical Device Clinical Trial Regulations in 2020 Free Webinar: An Overview of China and Europe Medical Device Regulations with Case Study on Surgical Mask 【NMPA】The results of Sampling Inspection of Medical Device Supervision (No.5)The Regulations on Supervision and Administration of Medical Devices (Revised Draft) was adopted Technical Guidelines of use IVD overseas Clinical Trial Data (draft for comment)【NMPA】Announcement on Approval of 73 Medical Device in October NMPA - An Interpretation on Drug and Medical Device Combination Product 【NMPA】 Analysis of the Related Matters about Imported Medical Devices Manufacturing in China (Announcement NO.40 2020)CFDA, NMPA Guideline for Medical Device Registration in China 【NMPA】Announcement on the Production of Imported Medical Devices in China related matters (NO.104, 2020)NMPA, Announcement on Imported Certificated Medical Devices product Transfer to Domestic Production in China The Revision of Class III Medical Devices that Need to be Approved for Clinical Trial ( revised in 2020)[NMPA] New and Revised Catalogue of Medical Devices Exempted from Clinical Trials (Draft for Comment)The Class III Medical Devices that Need to Be Approved for Clinical Trials (Revised in 2020, Draft for Comments)[Clinical Trial] Superiority Trial of Medical Device Clinical Trial Design [Clinical Trial] Non-inferiority Trial of Medical Device Clinical Trial [Clinical Trial] Factors Affecting the Estimation of the Sample Size of Clinical Trials of Medical Devices Medical Device Overseas Clinical Trial Data for Registration in China [NMPA] The Content Adjustment of the "Medical Devices Classification Catalogue"[UDI Database] Medical Device Unique Identification Database Is Open to the Public [Important] How to Check the Registration Information of Anti-epidemic Medical Device Products China's First Medical Device Approved for Marketing by Using Domestic Clinical Real-World Data

Company News

Events

Free Webinar: Regulatory Activities of China Medical Device in 2022 Free Webinar: Regulatory Activities of China Medical Device in 2021 Free Webinar-Overview of Chinese Medical Device Regulations-Korea Branch

About

China Medical Device Label and Manual Requirements

Sep 19, 2017 by CIRS Lou

On July 30th 2014, China Food and Drug Administration (CFDA) issued the registration regulation about ‘Medical Device Manual and Label Management Regulation’. All the medical device that market in China should compile the manual and label corresponding to this regulation.

Definition

Medical Device Manual---The technical document compiled by the product registrant or filer for providing the basic safety information of product installation, debugging, operation and maintenance to the users.
Medical Device Label---Labels are the words descriptions and graphic symbols on the medical device or packaging for identifying product features and indicate safety warnings.

The Main Requirements for the Medical Device Manual and Label Compiling

Product manual and label shall be scientific, realistic, complete, accurate and consistent with the product features.
Product manual and label shall be consistent with the filing or registration contents.
Product label shall be conformed to the content in the product manual.
Product label contents from the manual, so it shall not exceed the range of the product manual.
Product manual and label shall use the unification issued or normative terminologies and national standard units for the description of the diagnosis and disease name.
The main content requirements for the product manual and label
What kind of content that product manual and label shall not include

CFDA Post-marketing Supervision-- Medical Device Quality Sampling
According to the CFDA Announcement about Strengthening the Medical Device Sampling Work, CFDA keep strengthening their supervision on the medical device. And medical device label and manual compiling is still a challenge for the manufactures.
Sample. (Click here to see the detailed statistic about CFDA medical device quality sampling.)

CIRS Medical Device Manual and Label Compiling Service
If you have any questions about medical device label and manual compiling, please feel free to contact CIRS at md@cirs-group.com.
Label sample:

We have launched a LinkedIn newsletter to keep you up to date on the latest developments across the chemical industry including food and FCMs and personal and home care.

Previous: The New Registered Medical Device Catalog

Next: CFDA Post-marketing Supervision-- Medical Device Quality Sampling (Jan-Sep, 2017)

0:00

/

0:00

加载完毕: 0%

进度: 0%

媒体流类型直播

0:00

file ID:

request ID:

media type:

mime type:

provider:

resolution:

rate:

frames:

buffer:

connection speed:

info:

[X]

Contact Us

+86 571 8720 6559 （GMT+8 8:30~17:00）

md@cirs-group.com

Contact Us

+86 571 8720 6559 （GMT+8 8:30~17:00）

md@cirs-group.com