| REGULATORY AGENCY | National Medical Products Administration (NMPA) |
| REGULATION NAME | Implementation of UDI |
| COMPLIANCE DATES | High risk class III (active and passive implants): 1 January 2021 Rest Class III: 1st June 2022 Class II: 1st August 2024 The rest: 1st August 2026 |
| APPLIES TO | These devices shall be assigned a UDI and their related data shall be uploaded into the UDI database before they are put on the market for sale. The production date shall be used to confirm whether the device must have a UDI or not, not matter the device is a newly licensed item or not. |
| BARCODE SYMBOLOGY | GS1 DataMatrix (inter alia, ID/linear bar code, 2D/Matrix bar code, RFID) |
| BARCODE CONTENTS |
|
| SERIAL NUMBER RANDOMIZATION | NA |
| SERIAL NUMBER REUSE |
No |
| HUMAN READABLE EXPIRY DATE FORMAT |
YYMMDD |
| BARCODE DATA ENCODING |
UDI – DI |
| PRODUCT CODE NOTES |
|
| FREE SAMPLES MUST BE MARKED? |
Not Specified |
| BARCODE SYMBOLOGY | GS1 DataMatrix (inter alia, ID/linear bar code, 2D/Matrix bar code, RFID) |
| BARCODE CONTENTS |
|
| SERIAL NUMBER RANDOMIZATION | NA |
| SERIAL NUMBER REUSE |
No |
| HUMAN READABLE EXPIRY DATE FORMAT |
YYMMDD |
| BARCODE DATA ENCODING |
UDI – DI |
| PRODUCT CODE NOTES |
|
| FREE SAMPLES MUST BE MARKED? |
No |
| BARCODE SYMBOLOGY | SSCC |  |
|
| BARCODE CONTENTS | GS1-128 (SSCC) | ||
|
PARENT-CHILD MAPPING AGGREGATION CAPTURE? |
Yes |
| SEND UNIT DATA TO GOVERNMENT REPOSITORY? | Yes (NMPA UDI information management system) |
| SEND UNIT DATA TO THIRD-PARTY REPOSITORY? |
Not Specified |
| SEND UNIT DATA TO TRADING PARTNER? |
Not Specified |
| SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY? | Yes |
| SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY? |
Not Specified |
| SEND AGGREGATION DATA TO TRADING PARTNER? |
Not Specified |
| WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION? | NMPA |
| MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY? |
Yes (Import & Exports) |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT? |
Yes |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT? | Yes |
| MANUFACTURER ACTIVITY REPORTED? | Yes |
| DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED? |
Yes |
| REGULATORY AGENCY | China National Medical Products Administration (NMPA) |
| REGULATION NAME | Guidelines for drug traceability information system construction |
| COMPLIANCE DATES | Both standards "Guidelines for drug traceability information system construction" and "Encoding requirements for drug traceability" have to be implemented from the date of publication (April 2019) The deadline for achieving traceability of the key products is 31st December 2020. |
| APPLIES TO | Marketing authorization holders, drug manufacturers, pharmaceutical operating units to establish the drug traceability systems and drug supervision and management departments of supervision and inspection. It does NOT apply to the production and operation of Chinese herbal medicines, raw materials and special packaging preparations |
| BARCODE SYMBOLOGY | linear/2D barcode, RFID, and HRI |
| BARCODE CONTENTS | Structure of the drug traceability code: drug identification code + production
identification code + check digit Drug identification code should be unique at each packaging level, and production identification code should include serial number, and can include lot number, production date, expiry date based on actual needs. Currently two coding system are still issued in China:
|
| SERIAL NUMBER RANDOMIZATION | NA |
| SERIAL NUMBER REUSE |
No |
| HUMAN READABLE EXPIRY DATE FORMAT |
YYMMDD |
| BARCODE DATA ENCODING |
GS1 standard |
| PRODUCT CODE NOTES |
Drug identification code should be unique at each packaging level, and production identification code should include serial number, and can include lot number, production date, expiry date based on actual needs. |
| FREE SAMPLES MUST BE MARKED? |
No |
| BARCODE SYMBOLOGY | SSCC | |
|
| BARCODE CONTENTS | GS1-128 (SSCC) | ||
|
PARENT-CHILD MAPPING AGGREGATION CAPTURE? |
No |
| SEND UNIT DATA TO GOVERNMENT REPOSITORY? | Proposed |
| SEND UNIT DATA TO THIRD-PARTY REPOSITORY? |
Not Specified |
| SEND UNIT DATA TO TRADING PARTNER? |
Not Specified |
| SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY? | Yes (Through Ali-Health) |
| SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY? |
Not Specified |
| SEND AGGREGATION DATA TO TRADING PARTNER? |
Not Specified |
| WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION? | NMPA |
| MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY? |
Proposed (Import & Exports) |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT? |
No Specified |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT? | No Specified |
| MANUFACTURER ACTIVITY REPORTED? | Yes (Proposed) |
| DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED? |
No Specified |
Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.
Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.
Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.
For Further Information, please contact our Compliance Team at info@kevision.in