1、 What Is The Unique Identification Of Medical Devices?
The Unique Identification Of Medical Devices Consists Of Product Identification And Production Identification. The Product Identification Is The Unique Code To Identify The Registrant / Filer, Model, Specification And Package Of Medical Devices. It Is The "Keyword" To Obtain Relevant Information Of Medical Devices From The Database, And It Is The Necessary Part Of The Unique Identification. The Production Identification Includes Information Related To The Production Process, Including Product Batch Number, Serial Number And Production Date Period And Expiration Date, Etc., Can Be Used In Combination With Product Identification To Meet The Needs Of Fine Identification And Record In The Circulation And Use Of Medical Devices.
The Principle Of Uniqueness, Stability And Scalability. Uniqueness Is The First Principle, The Basis To Ensure The Accurate Identification Of Products, And The Core Principle Of The Function Of Unique Identification. Due To The Complexity Of Medical Devices, The Uniqueness Shall Be Consistent With The Requirements Of Product Identification. For Medical Devices With The Same Characteristics, The Uniqueness Shall Point To A Single Specification And Model Product; For Products Controlled By Batch Production, The Uniqueness Shall Point To The Same Batch Of Products; For Medical Devices Controlled By Serial Number Production, The Uniqueness Shall Point To A Single Product.
Stability Means That Once The Unique Identification Is Assigned To The Medical Device Product, As Long As Its Basic Characteristics Have Not Changed, The Product Identification Should Remain Unchanged. When The Sales And Use Of Medical Devices Are Stopped, The Product Identification Shall Not Be Used For Other Medical Devices; When The Sales And Use Are Resumed, The Original Product Identification Can Be Used.
Extensibility Refers To That The Unique Identification Should Adapt To The Regulatory Requirements And The Continuous Development Of Practical Applications. The Word "Unique" Does Not Mean That The Serial Number Management Of A Single Product Is Carried Out. In The Unique Identification, The Production Identification Can Be Used In Combination With The Product Identification To Achieve The Uniqueness Of Three Levels: Specification, Model, Batch And Single Product, So As To Meet The Current And Future Requirements For Medical Devices Identify Requirements.
2、 Why To Build A Unique Identification System For Medical Devices?
Medical Technology, Drugs And Medical Devices Are The Three Pillars Of The Medical Service System. Medical Devices Involve Sound, Light, Electricity, Magnetism, Image, Materials, Mechanics And Nearly One Hundred Professional Disciplines. They Are Internationally Recognized High-Tech Industries, With The Characteristics Of High-Tech Intensive, Interdisciplinary, Technology Integration And Integration, And Represent The Comprehensive Strength Of A Country's High-Tech. In Recent Years, With The Rapid Development Of Medical Device Industry, New Technologies And Products Emerge In An Endless Stream, And The Product Diversity And Complexity Are Constantly Improving. There Is No Code Or One Thing With Multiple Codes In The Circulation And Use Of Medical Devices, Which Seriously Affects The Accurate Identification Of Medical Devices In The Production, Circulation And Use Of Medical Devices, And It Is Difficult To Achieve Effective Supervision And Management.
Unique Device Identification (UDI) Is The ID Card Of Medical Devices. The Unique Identification System Of Medical Devices Consists Of Unique Identification, Data Carrier And Database. Giving Each Medical Device An ID Card, Realizing The Transparency And Visualization Of Production, Operation And Use, And Improving The Traceability Of Products Are The Key To The Innovation Of Medical Device Supervision Means And The Improvement Of Supervision Efficiency. It Will Play A Positive Role In Strictly Abiding By The Bottom Line Of Medical Device Safety And Helping The High-Quality Development Of Medical Device Industry. Therefore, The Construction Of The Unique Identification System Of Medical Devices In China Is In Urgent Need.
The Unique Identification Of Medical Devices Is The Focus And Hot Spot In The Field Of International Medical Device Regulation. In 2013, The International Medical Device Regulatory Body Forum (Imdrf) Issued The Guidance Of The Unique Identification System Of Medical Devices. In The Same Year, The United States Issued Regulations On The Unique Identification System For Medical Devices, Which Requires The Full Implementation Of The Unique Identification System For Medical Devices Within 7 Years. In 2017, EU Legislation Required The Implementation Of The Unique Identification Of Medical Devices. Japan, Australia, Argentina And Other Countries Have Also Carried Out Relevant Work, And The Global Unique Identification Of Medical Devices Has Been Continuously Promoted.
In 2012, The State Council Issued The National Drug Safety Plan For The 12th Five Year Plan, Which Called For "Launching The National Unified Coding Of High-Risk Medical Devices". In 2016, The State Council Issued The 13th Five Year Plan For National Drug Safety, Which Requires "Building A Medical Device Coding System And Formulating Rules For Medical Device Coding". In 2019, The General Office Of The State Council Issued The Key Tasks Of Deepening The Reform Of The Medical And Health System In 2019, Which Requires "Formulating The Rules For The Unique Identification System Of Medical Devices", Which Was Deliberated And Approved By The Eighth Meeting Of The Central Comprehensive Deepening Reform Committee. In The "Reform Plan For The Treatment Of High-Value Medical Consumables" Issued By The General Office Of The State Council, It Clearly Puts Forward "Formulating The Unique Identification System Of Medical Devices" Unified Rules ". In July 2019, The State Food And Drug Administration, Together With The National Health And Health Commission, Jointly Issued The Pilot Work Plan For The Unique Identification System Of Medical Devices, Marking The Beginning Of The Construction Of The Unique Identification System Of Medical Devices In China.
3、 What Is The Significance Of Building A Unique Identification System For Medical Devices?
Through The Establishment Of A Unique Identification System For Medical Devices, It Is Conducive To The Integration And Sharing Of Regulatory Data, The Innovation Of Regulatory Model, The Improvement Of Regulatory Efficiency, The Strengthening Of Life Cycle Management Of Medical Devices, The Purification Of The Market, The Optimization Of Business Environment, The Combination Of Government Regulation And Social Governance, The Formation Of A Situation Of Social Governance, The Promotion Of Industrial Transformation, Upgrading And Healthy Development, And The Provision Of More We Will Increase Safe And Efficient Medical Services And Enhance People's Sense Of Access.
From The Industrial Point Of View, For Medical Device Manufacturers, The Use Of Unique Logo Is Conducive To Improving The Level Of Enterprise Information Management, Establishing A Product Traceability System, Strengthening Industry Self-Discipline, Improving Enterprise Management Efficiency, And Promoting The High-Quality Development Of Medical Device Industry. For Medical Device Business Enterprises, The Use Of Unique Identification Can Establish A Modern Logistics System, And Realize The Transparency, Visualization And Intelligence Of The Medical Device Supply Chain. For Medical Institutions, The Use Of Unique Identification Is Conducive To Reducing Equipment Errors, Improving The Management Level Of Consumables In Hospital, And Maintaining The Safety Of Patients.
From The Perspective Of Government Management, For The Supervision Of Medical Devices, The Use Of Unique Identification Can Build Big Data For The Supervision Of Medical Devices, Realize The Source Of Medical Devices Can Be Checked, The Destination Can Be Traced, The Responsibility Can Be Investigated, And Realize Intelligent Supervision. For The Health Administration Department, The Use Of Unique Identification Can Strengthen The Standardized Management Of Medical Equipment Behavior, Promote The Establishment Of Health Care Big Data, Improve The Efficiency Of Health Management, And Help The Health China Strategy. For The Medical Insurance Department, It Helps To Accurately Identify Medical Devices In The Procurement Bidding, Promote The Transparency Of Settlement, And Combat Fraud And Abuse.
From The Perspective Of The Public, Through Information Disclosure And Data Sharing, Consumers Can Use And Understand Consumption At Ease, And Effectively Safeguard The Legitimate Rights And Interests Of Consumers.
4、 What Are The Principles For The Implementation Of The Unique Identification Of Medical Devices?
The Rules For The Unique Identification System Of Medical Devices (Hereinafter Referred To As The Rules) Require That The Construction Of The Unique Identification System Should Actively Learn From International Standards And Follow The Principles Of Government Guidance, Enterprise Implementation, Overall Promotion And Distribution Implementation. In Order To Better Promote International Exchanges And Trade, And Optimize The Business Environment, The Construction Of China's Unique Identification System Draws Lessons From Internationally Accepted Principles And Standards. Establish A Unique Identification System, The Government Plays A Leading Role, The Registrant / Recorder As The First Responsible Person Is Responsible For Implementation, And Actively Apply Unique Identification To Improve Product Quality And Enterprise Management Level. Due To The Diversity And Complexity Of Medical Devices, The Implementation Of Unique Identification Step By Step Is An Internationally Accepted Practice. China's Medical Devices Are Managed According To The Risk Level. Based On The Practical Experience Of The International Unique Identification, Combined With The Actual Situation Of China's Medical Device Industry And Supervision, A Step-By-Step Implementation Policy Is Formulated. Compared With The United States And Europe, The Implementation Of Unique Identification In China Has Increased The Pilot Link, Mainly Some High-Risk Implant / Interventional Medical Devices, With A Smaller Coverage, To Ensure The Steady Progress Of The Rules.
5、 How To Realize The Aggregation And Sharing Of Unique Identification Data?
The Data Collection And Sharing Of The Unique Identification Of Medical Devices Are Realized Through The Unique Identification Database Of Medical Devices, Which Is Organized And Constructed By The State Drug Administration. The Registrant / Recorder Uploads The Product Identification And Related Information Of The Unique Identification To The Database According To The Relevant Standards And Specifications, And Is Responsible For The Accuracy And Uniqueness Of The Data. Medical Device Business Enterprises, Medical Institutions, Relevant Government Departments And The Public Can Share Unique Identification Data Through Data Query, Download, Data Docking And Other Ways.
6、 Do The Products Listed Before The Implementation Of The Rules Need To Be Given A Unique Identification?
From The Implementation Date Of The Rules, The Registrant / Filer Shall Submit Its Product Identification In The Registration / Filing Management System When Applying For Registration, Registration Change Or Filing Of Relevant Medical Devices. The Relevant Medical Device Products Shall Be Given A Unique Identification During The Production Process, And The Upload Of The Unique Identification Product Identification And Relevant Data Of The Medical Device Shall Be Completed Before The Products Are Put On The Market.
The Medical Devices That Have Been Produced And Sold Before The Implementation Date Of The Rules May Not Have The Unique Identification Of Medical Devices.
7、 How To Choose The Unique Identification Data Carrier Of Medical Devices?
At Present, The Common Data Carriers On The Market Include One-Dimensional Code, Two-Dimensional Code And Radio Frequency Tag (RFID).
One Dimensional Code Is A Bar Code Symbol That Only Represents Information In One Dimensional Direction. It Has Been Used For Many Years And Has Low Cost. It Can Be Well Compatible With The Existing Code Scanning Equipment On The Market, But One-Way Code Occupies A Large Space And Has Poor Ability Of Damage Correction.
Two Dimensional Code Is A Bar Code Symbol That Represents Information In Two-Dimensional Direction. Compared With One-Dimensional Code, The Same Space Can Accommodate More Data, Which Can Play A Good Role When The Packaging Size Of The Device Is Limited. It Has Certain Error Correction Ability, But The Requirements For Reading Equipment Are Higher Than One-Dimensional Code.
The RFID Tag Has The Function Of Information Storage, Which Can Receive The Electromagnetic Modulation Signal Of The Reader And Return To The Data Carrier Of The Corresponding Signal. Compared With One-Dimensional Code And Two-Dimensional Code, The Carrier Cost And Reading Equipment Cost Of RFID Tag Are Higher, But RFID Reading Speed Is Fast, It Can Achieve Batch Reading, And It Can Play A Role In Some Links And Fields.
The Registrant / Recorder Can Select The Appropriate Unique Identification Data Carrier Of Medical Device According To The Characteristics, Value, Main Application Scenarios And Other Factors Of The Product.
The Registrant / Recorder Can Select The Appropriate Unique Identification Data Carrier Of Medical Device According To The Characteristics, Value, Main Application Scenarios And Other Factors Of The Product.
8、 What Kind Of Qualification Does The Code Issuing Agency Need, And What Are Its Responsibilities And Obligations?
The Code Issuing Institution Of The Unique Identification Of The Device Shall Be A Legal Entity Within The Territory Of China, With A Perfect Management System And Operation System, To Ensure The Uniqueness Of The Unique Identification Of The Medical Device Created In Accordance With Its Standards, And Meet The Relevant Requirements Of Data Security In China.
The Code Issuing Institution Shall Provide The Registrant / Record Holder With The Process Of Implementing The Standard And Guide The Implementation. In Order To Facilitate The Registrant / Record Holder To Master The Code Standard Of The Code Issuing Institution For Relevant Parties To Choose Or Apply, The Code Issuing Institution Shall Upload Its Code Standard To The Unique Identification Database Of Medical Devices And Dynamically Maintain It. Before January 31 Of Each Year, The Issuing Agency Shall Submit To The SDA A Report Of The Previous Year On The Unique Identification Created In Accordance With Its Standards.
9、 What Is The Process For The Registrant / Filer To Implement Unique Identification?
The Process For The Registrant / Filer To Implement The Unique Identification Is As Follows:
Step 1: The Registrant / Filer Shall Select The Code Issuing Institution According To The Rules And Relevant Standards And The Actual Situation Of The Enterprise.
Step 2: The Registrant / Filing Person Creates The Product Identification According To The Standards Of The Issuing Organization And Determines The Composition Of The Product Production Identification.
Step 3: From The Date Of Implementation Of The Rules, If Applying For Registration, Registration Change Or Filing Of Medical Devices, The Registrant / Filing Person Shall Submit Product Identification In The Registration / Filing Management System.
Step 4: The Registrant / Recorder Shall Select The Appropriate Data Carrier According To The Standards Of The Coding Institution, And Give The Medical Device A Unique Identification Data Carrier To The Minimum Sales Unit And Higher-Level Packaging Or Medical Device Products.
Step 5: The Registrant / Recorder Shall Upload The Product Identification And Relevant Information To The Unique Identification Database Of Medical Devices Before The Product Is Put On The Market.
Step 6: When The Product Identification And Data Related Information Changes, The Registrant / Recorder Shall Update The Unique Identification Database Of Medical Devices In Time.
Post time: Aug-27-2019
