General Medical Device Labeling and Packaging Requirements


The label of a device shall specify conspicuously following matters:
  1. 1. common name, model and specifications of the product.
  2. 2. name, address and contact information of the registrant or recorder and the after-sale service department, for imported device, the name, address and contact information of agent are required as well.
  3. 3. name, address manufacture address and contact information of the manufacturer and the serial number of production license or record, for sub-contract production, above items of the commissioned corporation are required as well.
  4. 4. serial number of the registration certificate or record of the medical device.
  5. 5. date of manufacture and expiration date.
  6. 6. connection condition and input power of the power source.
  7. 7. diagrams, symbols and other relevant items that shall be marked in view to the product properties.
  8. 8. requisite caution and warning.
  9. 9. special storage and operation instruction.
  10. 10. device that may destroy or have adverse impacts on environment shall be marked with warning symbol or instruction.
  11. 11. device that will give radiation shall be marked with warning symbol or instruction.
    Labels those cannot contain all of above matters caused by the position or limited scope shall at least involve the name, model, specification, manufacture date and expiration date of the product, and point that “see the manual for details” as well.

     

The manual/package insert of a device shall specify conspicuously following matters:

  1. 1. common name, model and specifications of the product.
  2. 2. name, address and contact information of the registrant or recorder and the after-sale service department, for imported device, the name, address and contact information of agent are required as well.
  3. 3. name, address manufacture address and contact information of the manufacturer and the serial number of production license or record, for sub-contract production, above items of the commissioned corporation are required as well.
  4. 4. serial number of the registration certificate or record of the medical device.
  5. 5. serial number of product’s technical requirement.
  6. 6. product performance, composition and scope of use.
  7. 7. contraindication, warning, general caution and other alerts.
  8. 8. instruction or diagram for installation and use, medical device that used by individual consumer shall indicate the specific safety instruction.
  9. 9. maintenance methods, special storage instruction and transportation condition of the product.
  10. 10. date of manufacture and expiration date.
  11. 11. accessories list, including the change period and change method.
  12. 12. explanation for diagrams, symbols and abbreviations marked on labels.
  13. 13. establishment or revision date of the instruction manual.
  14. 14. other matters.
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