Another major regulation in the field of medical devices will be introduced。 8May 22nd，The State Administration for Market Regulation issued a notice on publicly soliciting opinions on the Rules for the Unique Identification System for Medical Devices (Draft for Comments).，It aims to strengthen the research and development of medical devices、produce、Supervision and management of operation and use，Improve the efficiency of supervision and management。 Definition of a "unique identification system".，Draft，Unique identification system for medical devices，Refers to the unique identification of a medical device、A unified identification system for medical devices composed of a unique identification data carrier and a unique identification database。 A unique identifier is a number that appears on a medical device product or packaging、A code made up of letters or symbols，It is used for unique identification of medical devices。 The unique identification data carrier is the data medium that stores or transmits the unique identification of medical devices。 A unique identification database is a database that stores the product identification and associated information of the unique identification of medical devices。 thereinto，The unique identifier shall include the product identifier and the production identifier。 Product identification is used to identify a medical device marketing authorization holder、A unique code for the medical device model, specification, and packaging；The production mark is a code that contains information about the production process of a medical device，According to regulatory and practical application needs，A medical device serial number may be included、Production lot number、Date of manufacture、Expiration date。 meantime，The National Medical Products Administration formulates standards and specifications related to the unique identification data of medical devices，Organize the establishment of a database of unique identification of medical devices，For public enquiries。 The "Opinion Draft" is hereby open to the public to solicit comments on the Consultation Draft，All sectors of the community can log on to the Chinese Government Legal Information Network (website) before September 21, 2018：http://www.chinalaw.gov.cn）, Enter the "Legislative Opinion Collection" column on the main menu of the homepage to put forward opinions and suggestions。 Full text of the attached draft Chapter 1 General Provisions Article 1 [Legislative purpose] is to establish a unique identification system for medical devices，Strengthen the research and development of medical devices、produce、Supervision and management of operation and use，Improve the efficiency of supervision and management，Innovate the regulatory model of medical devices，According to the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices，These rules are enacted。 Article 2: [Applicable Objects] Sales within the territory of the People's Republic of China、The medical devices used shall comply with the requirements of these rules。 Article 3 [Definition of Unique Identification System] The unique identification system for medical devices referred to in these Rules，Refers to the unique identification of a medical device、A unified identification system for medical devices composed of a unique identification data carrier and a unique identification database。 The unique identification of a medical device refers to the number presented on the product or packaging of the medical device、A code made up of letters or symbols，It is used for unique identification of medical devices。The data carrier of the unique identification of medical devices is the data medium for storing or transmitting the unique identification of medical devices。The unique identification database of medical devices is a database that stores the product identification and associated information of the unique identification of medical devices。 Article 4 [Construction Principles] The construction of the unique identification system for medical devices should actively learn from international standards，Follow the implementation of the main body of the enterprise、Regulatory guidance、Classification is implemented step by step、The principle of overall coordination between all parties。 Article 5 [Responsibilities] The State Drug Administration is responsible for establishing a unique identification system for medical devices，Formulate and publish the implementation plan for the unique identification system of medical devices，Promote all parties to actively apply the unique identification of medical devices for management，Realize data interconnection。 Chapter 2 Unique Identification of Medical Devices Article 6 [Composition of Unique Identification] The unique identification of medical devices shall include product identification and production identification。Product identification is used to identify a medical device marketing authorization holder、A unique code for the medical device model, specification, and packaging；The production mark is a code that contains information about the production process of a medical device，According to regulatory and practical application needs，A medical device serial number may be included、Production lot number、Date of manufacture、Expiration date。 Product occurrence may affect medical device identification、Retrospectively or when regulatory requirements change，A new product identity should be created。 When the sale of medical devices is discontinued、When in use，The product identification shall not be used for other medical devices；Re-sell、When in use，The original product logo can be used。 Article 7 [Basic Principles of Unique Identification] The unique identification of medical devices shall comply with uniqueness、Principles of stability and scalability。 uniqueness：The unique identification of medical devices shall be consistent with the identification requirements of medical devices。 stability：The unique identification of medical devices shall be related to the basic characteristics of the product，If the basic characteristics of the product have not changed，Product labeling should remain the same。 Scalability：The unique identification of medical devices should be adapted to the continuous development of regulatory requirements and practical applications。 Article 8 [Requirements for the Creation of Unique Identification] The marketing authorization holder of medical devices shall create it in accordance with the standards for the preparation of unique identification of medical devices、Maintain unique identification of medical devices。The standards for the compilation of unique identification of medical devices include the relevant standards formulated by the coding agency or the State Drug Administration that meet the requirements of Article 9 of these Rules。 Article 9: [Requirements for Code Issuing Bodies] Code issuing bodies shall be legal entities within the territory of China，And it should have a sound management system and operation system to ensure the uniqueness of the unique identification of medical devices created in accordance with its standards，and comply with the relevant requirements of national data security。The code issuing authority shall provide the medical device marketing authorization holder with the process for implementing its standards and guide the implementation，and provide the NMPA with a report of a unique identifier created in accordance with its standards by January 31 of each year。 The state encourages code issuing institutions to adopt relevant international standards to establish a unique identification operation system。 Chapter 3 Uniquely Identified Data Carriers Article 10 [Requirements for Uniquely Identified Data Carriers] The uniquely identified data carriers of medical devices shall meet the requirements of automatic identification and data collection technology and manual reading。If space is limited or the use is limited，In principle, the carrier form that conforms to the automatic identification and data acquisition technology is preferred。 Automatic identification and data acquisition technologies include 1D codes、QR code or radio frequency tag, etc，Encourage the use of advanced automatic identification and data collection technologies。 When using 1D codes，Product identification and production identification can be concatenated，Multiple lines can also be connected in parallel；When using RF tags，It should also have a 1D code or a QR code。 Article 11 [Requirements for Granting Uniquely Identified Data Carriers] The marketing authorization holder of medical devices shall select the data carrier standards that are compatible with the unique identification of medical devices created by the medical device，The packaging of the sales units of medical devices at all levels or the medical device products listed in its name shall be given a unique identification data carrier，And ensure that the uniquely identified data carrier is firm during the operation and use of medical devices、clarity、Readable。 Chapter 4 Unique Identification Database Article 12 [Unique Identification Database] The unique identification database of medical devices contains the product identification and related data of medical devices。 The National Medical Products Administration formulates standards and specifications related to the unique identification data of medical devices，Organize the establishment of a database of unique identification of medical devices，For public enquiries。 Article 13 [Responsible entity for coding] The marketing authorization holder of medical devices shall upload it in accordance with the requirements of relevant standards or specifications、Maintain and update relevant data in a uniquely identified database，and the authenticity of the data、Accuracy is responsible。 Article 14 [Requirements for Submission of Unique Identification Data] The marketing authorization holder of a medical device shall be approved for registration of its products、Within 60 working days after obtaining the filing or change，And upload the product identification and related data to the unique identification database of medical devices before the product is put on sale。 Chapter 5 Supplementary Provisions Article 15 [Requirements for the Use of Unique Identification] The drug regulatory department may call and manage relevant data according to regulatory needs。 Encourage medical device production and operation enterprises and users to apply the unique identification of medical devices，Adopt advanced information technology to carry out product-related management。 Article 16 Read More …
