Pre-Announcement of Administration of the (Proposed) Legislation of Management Guidelines for Display and Management of Unique Device Identifier

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1 MFDS Notification No In establishing the "Management Guidelines for Display and Management of Unique Device Identifier", we are notifying the public in order to gather public views prior to enactment of the guidelines. Therefore, in accordance with Article 46 of the Administrative Procedures Act, we hereby notify the public of the proposed enactment as well as the reasons for and principal details of the proposed enactment, etc. August 8, 2018 The Minister of Food and Drug Safety Pre-Announcement of Administration of the (Proposed) Legislation of Management Guidelines for Display and Management of Unique Device Identifier 1. Reasons for Legislation Amendment to the Medical Device Act (Statute 14330, December 2, 2016) (Promulgation) In accordance with the amendments to this act, it is necessary to provide details regarding the guidelines for generating and displaying the unique device identifier (UDI) that must be labeled on a container or an outer package of a medical device, etc., as mandated by law. 2. Principal Details The intention here is to regulate the standards for display and management of unique device identifiers, including the generation of unique device identifiers, the display and method of attaching medical -1-

2 device barcodes and RFID (Radio Frequency Identification) tags, any exceptions in the application of unique device identifiers, etc. 3. Submission of Views Organizations and individuals who wish to express their views on the proposed legislation of "Guidelines for Display and Management of Unique Device Identifiers" should submit a written opinion containing the following points to the Minister of Food and Drug Safety (c/- Medical Device Policy Dept., MFDS, 187 Osongsaengmyeong 2- ro, Osong-eup, Hongdeok-gu, Chongju-shi, Chungcheongbuk-do, Postal Tel.: , Fax: , bgkim81@korea.kr) on or before August 28, 2018: A. Views regarding the items raised in the pre-announcement (whether for or against, and the reasons thereof) B. Name (in the case of an organization, the organization name and name of its representative), address and telephone number C. Other notes or comments -2-

3 Proposed Legislation of Guidelines for Display and Management of Unique Device Identifiers for Medical Devices Article 1 (Purpose) In accordance with Article 20, Paragraph (8) of the Medical Device Act (hereafter 'the Act'), this notification has the purpose of stipulating detailed information with regards to displaying and managing the unique device identifiers that must be labeled on the container or an outer package of medical devices that are either manufactured domestically or imported into South Korea. Article 2 (Definitions) The definitions of terms used in this notification are as follows: 1. The term "Unique Device Identifier" (UDI) refers to a combination of numbers and letters written or marked on the container or an outer package of a medical device in accordance with a standardized system for the purpose of identifying and managing, both systematically and efficiently, medical devices. A UDI is comprised of a device identifier (UDI-DI) and a device production identifier (UDI-PI). 2. The term "Device Identifier" (UDI-DI) refers to a part of the UDI that is a combination of numbers or letters uniquely generated for each product. The UDI-DI is a code that must be input into the Integrated Medical Device Information System in accordance with Article 31, Paragraph 3-2 of the Medical Device Act. 3. The term "Production Identifier" (UDI-PI) refers to the part of the UDI that is a combination of numbers and letters generated for each produced unit of a particular medical device. The UDI-PI must include the following information to be labeled on the container or an outer -3-

4 package of the device. A. Manufacturing lot number (manufacture unit no., batch no., or product serial no.) B. Date of manufacture (in cases where an expiration date exists, then the date of expiration can be labeled) C. Product version information (relevant only to medical device software) 4. The term "medical device barcode" refers to one of the following symbols (marks) that is printed in a format easily read by a machine as a means for automatically inputting a UDI into a computer system. A. A combination of black and white parallel bars with varying widths B. A matrix-type combination comprised of an assembly of square modules with a specific arrangement or sequence 5. The term "Radio Frequency Identification tag" (RFID tag) refers to a method for expressing a UDI using 'wireless recognition technology'. A RFID tag is generally comprised of a chip on which the serial no. of the UDI-PI component of a UDI is stored plus an antenna for transmitting the stored information. Article 3 (Scope of Application) This notification applies to medical devices distributed or sold in South Korea, and does not apply to medical devices produced for export. Article 4 (Generation of UDIs) (1) For any medical device approved, certified or notified in accordance with Article 6 Paragraph (2) or Article 15 Paragraph (2) of the Act, the device manufacturer or importer must generate a UDI using the minimum naming unit (individual model name, except in case of multiple product -4-

5 names for a single model, in which case the individual product name must be used in addition to the applicable GS1 International Standard System (Global Standard #1) shown in Attached Table 1 for each individual packing unit.). (2) A device manufacturer or importer to which Section A. above applies must re-generate the applicable UDI for any device in relation to which any one of the following changes occurs. 1. If the manufacturer or overseas manufacturer changes due to succession to the status, etc. 2. If the approval, certification or notification of medical device are handed over or ceded to another party 3. If the minimum naming unit (model name or product name) changes 4. If the packing unit changes 5. If the information related to single use or product sterilization changes 6. If there is a change to approved (certified, notified) items, such as the list of cautions for use (warnings or prohibitions), etc. Article 5 (Display of UDIs) (1) The manufacturer or importer of a medical device must display or attach the UDI generated in accordance with Article 4 on the container or an outer package of the medical device using one of the following methods, including a form of numbers or letters that can be read. 1. Medical device barcode 2. Medical device barcode and RFID tag (including an image or diagram notifying that an electronic tag is attached to the item) (2). Irrespective of Paragraph (1), any medical device corresponding to any of the following must permanently display the medical device -5-

6 barcode on an outer package of the medical device: 1. Medical devices that are specifically defined and announced by the Minister of Food and Drug Safety as medical devices capable of reuse within a medical institution 2. Medical devices that are specifically defined and announced by the Minister of Food and Drug Safety as medical devices that must be processed, i.e. sterilized, before use (3) Irrespective of Paragraph (1), in cases where medical device software is provided in a non-material format by means of a communications network, rather than digital media (that is, diskettes, CDs, etc.), the UDI can be made available by a method that allows the user to verify the item after it has been installed. Article 6 (Method for Displaying Medical Device Barcodes) (1) In cases where a medical device barcode is displayed on a medical device in accordance with Article 5, Paragraph (1), Item 1, the GS1 system barcode used must be either an EAN-13 (European Article Number-13) barcode, a GS1-128 barcode or a GS1 Datamatrix barcode. (2) The method for displaying the medical device barcode shall be as described in Attached Table 2. (3) In displaying the medical device barcode, the size, color and position of the printed barcode must comply with the details specified in Attached Table 3. Article 7 (Method for Attaching an RFID tag) (1) In cases where an RFID tag is displayed on a medical device in accordance with Article 5, Paragraph (1), Item 2, the GS1 system element used must be either SGTIN-96 (Serialized Global Trade Item -6-

7 Number-96) or SGTIN-198 (Serialized Global Trade Item Number-198). (2) The method for displaying the RFID tag shall be as described in Attached Table 4. (3) The selection standard and method of attaching the RFID tag, etc., shall be as indicated in Attached Table 5. Article 8 (Special Cases concerning the UDI) Irrespective of the stipulations in Article 4 Paragraph (1), Article 6 and Article 7, a medical device manufacturer or importer may generate and display a UDI using one of the following international standard systems. 1. HIBCC (Health Industry Business Communications Council) 2. ICCBBA (International Council for Commonality in Blood Banking Automation) Article 9 (Detailed Information) The Head of the Integrated Medical Device Information Center stipulated in Article 31-4 Paragraph (1) may separately stipulate further detailed information in cases where it is deemed necessary for the smooth management and operation of the UDI system. Article 10 (Review Time Limits) Under the "Regulations on Issue and Management of Instructions and Established Rules, etc." (Presidential Directive No. 334), any measures taken to abolish or amend, etc., this notification on the basis of examination of changes to law or real world circumstances following the promulgation of this notification shall be undertaken no later than December 31st,

8 Addendum This notification comes into effect on the enactment date of Article 20 of Act. No , Partial Amendment of the Medical Device Act. -8-

9 [Attached Table 1] Method for Generation of Unique Device Identifiers (UDI) (related to Article 4 Paragraph (1)) UDIs must be generated using the Application Identifier (AI) code system from GS1. In the case of Class 1 devices, however, it is possible to forego generation of a medical device production identifier (PI). Instead, the UDI can be generated using the GTIN-14 (Global Trade Item Number-14) code system (including GTIN-8, GTIN-12, GTIN-13). A. GTIN-14 code system Positional No. Content Generatio n example Logistics Unit Country Company Prefix Product Verification Classificatio No. n Total: 14 positions * In cases where the Company Prefix occupies position 4, the Product Classification occupies position 5 * In cases where the Company Prefix occupies position 5, the Product Classification occupies position 4 * In cases where the Company Prefix occupies position 6, the Product Classification occupies position 3 * In the case of a medical device sold as an individual unit, a "0" is generated for the logistics unit identifier. B. GS1 Application Identifier System Application Identifier Definition / / 21 GTIN-14 Date of manufacture / Expiration date Lot no. / Serial no. Data format 14 digit number 6 digit number 20 alphanumeric characters * Aside from the production identifier (PI), a manufacturer or importer may add an application identifier in accordance with the KS Standard (Standard No. KS X 6705) if deemed necessary. -9-

10 NB Example of generated Unique Device Identifier (UDI) Positional or less No. Content AI Brand Identifier GTIN-14 AI Date of manufacture YYMMDD AI Lot No. Product production line Generatio n example Q12345 Medical Device Unique Identifier (UDI-DI) Medical Device Production Identifier (UDI-PI) -10-

11 [Attached Table 2] Method for displaying medical device barcodes GS1 System GTIN-14 code system GS1 AI code system Display Unit EAN-13 GS1-128 GS1 Datamatrix GS1-128 GS1 Datamatrix A. EAN-13 barcode When a UDI is generated according to the GTIN-14 code system and displayed on an EAN-13 barcode, the logistics unit identifier "0" is omitted (only a total of 13 positions are input). EAN-13 barcode example B. GS1-128 barcode When a UDI is generated according to the GTIN-14 code system and displayed on a GS1-128 barcode, both the application identifier "01" and the logistics unit identifier "0" are included. GS1-128 barcode example (GTIN-14) When a UDI is generated according to the GS1 AI code system and displayed on a GS1-128 barcode, all application identifiers and data formats are included. GS1-128 barcode example (GS1 AI code) C. GS1 Datamatrix barcode When a UDI is generated according to the GTIN-14 code system and displayed on a GS1 Datamatrix 128 barcode, both the application identifier -11-

12 "01" and the logistics unit identifier "0" are included. (01) GS1 Datamatrix barcode example (GTIN-14) When a UDI is generated according to the GS1 AI code system and displayed on a GS1 Datamatrix barcode, all application identifiers and data formats are included. (11)180531(10)Q12345 (01) GS1 Datamatrix barcode example (GS1 AI code) -12-

13 [Attached Table 3] Print size, color and position of medical device barcodes (related to Article 6 Paragraph (3)) Classification EAN-13 GS1-128 GS1 Datamatrix Print Size - Width 3.73cm x height 2.59cm - Print at 0.8 ~ 2.0 x size within a barcode readable (decodable) range - Density (X-Dimension) 0.17mm or greater recommended - Density (X-Dimension) 0.25mm or greater recommended Print Color - Degree of contrast between black and white bars to be 75% or greater - Black color bars and white color bars (pattern) recommended - Degree of contrast between black and white bars to be 75% or greater - Black color bars and white color bars (pattern) recommended - Degree of contrast between black and white bars to be 75% or greater - Black color bars and white color bars (pattern) recommended - Use of metallic colors (gold, silver), etc., prohibited - Easy to read (decode) position - Easy to read (decode) position - Easy to read (decode) position Print Position - Edge limit 8mm recommended - Angle within 30 - Edge limit 8mm recommended - Angle within 30 - Angle within

14 [Attached Table 4] Method for Generation of Radio Frequency Identification (RFID) tags (related to Article 7 Paragraph (2)) SGTIN-96 and SGTIN-198 are comprised of the 12 positions of the unique device identifier excluding the verification number plus the logistics identifier and serial number, as shown below. The relevant Standard and Serial No. must be labeled on the RFID tag in legible characters. 1. SGTIN-96 1) Filter Class Header value 2) Partition 3) Company prefix Brand identifier No. of bits Value Positional No (fixed value) Standard filter value positions 6 positions Serial no. 4) Max. 2,74.8 billion Unique device identifier Class Positional No. Country Country Identifier Logistics 5) Identifier Product Classification SGTIN-198 1) Filter Class header value 2) Partition3) Company prefix Brand identifier Serial no. 4) No. of bits Value Positional No (fixed value) Standard filter value positions 6 positions Max. 20 positions Unique device identifier Class Positional No. Country Country Identifier Logistics 5) Identifier Product Classification

15 1) Header: defines the length of the code value as well as the format and structure of the identifier code. As a binary value, in case of SGTIN-96 applies ' ' and SGTIN-198 applies ' '. 2) Filter value: follows the most recent definition of the GS1 EPCglobal TDS (Tag Data Standard). Filter value Meaning Filter value Meaning 000 All Others 100 Trade item bundle that does not go through a checkout 001 Retail trade item 101 Reserved 010 Standard trade item bundle 110 Reserved for future use 011 Single shipping/consumer trade item 111 Reserved 3) Partition: the binary value "101" is applied in the 7th position in the company prefix and the 6th position in the product code as an identifier for distinguishing the length of the company prefix and the product code. 4) Serial number: as a serial number generated in order to identify individual products, the SGTIN-96 can be comprised exclusively of numbers and encodes a decimal number as a binary number. SGTIN-198 can be comprised of a mix of alphanumeric characters, and each of the alphanumeric characters must conform to ISO/IEC 646(ASCII) encoding and be encoded with 7 bits each. 5) Logistic identifier: applied as a binary value '000' when applied to individual medical device products. -15-

16 [Attached Table 5] Criteria for selecting Radio Frequency Identification (RFID) tags and method of attachment, etc. (related to Article 7 Paragraph (3)) 1. Criteria for selecting RFID tags A. Use a 900MHz band passive RFID tag that applies the ISO C standard. B. It is recommended that a tag is used that has received a certification from the Test Lab that includes the results of reliability tests, such as a high temperature operation test, low temperature operation test, high temperature high humidity test and temperature change test, etc., and also includes the results of Tag RF/Protocol standards tests and interoperability tests. C. An RFID tag must be recognizable at a minimum of 1m from the item in question. 2. Method of attaching RFID tags A. General Standard An RFID tag must be attached in such manner that it does not limit the use or storage of the medical device. B. Method of attaching per different medical device packing materials, etc. Must be attached in a fixed manner to a cardboard box, to plastic and glass packing materials, films (sheet) packing materials, etc. Recognition must not be hindered during transport phase. 3. RFID reader A. A 900MHz band passive reader [KS xiso/iec c] is recommended. B. It is recommended to use a reader that has received a certification from the Test Lab that includes the results of standards tests and interoperability tests. -16-