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Non Food Medical device Add-on
Medical Device Add-on
1.1.1 Is there documented precautionary guidance regarding adverse reactions and risk management measures?
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Risk management on adverse reactions:
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1.1.2 Is the complete product registration dossier maintained, including pharmacology and toxicology data, clinical data, quality standards, manufacturing process descriptions, and packaging and labeling information?
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Product registration profile:
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1.1.3 Is there documented and defined appropriate intervals for equipment validation, process validation, cleaning validation, change control processes and deviation/corrective action plan?
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Records of equipment validation, process validation, cleaning validation, change control of last year:
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1.1.4 Is there an environmental monitoring plan in place to ensure proper operating conditions and do ATP based on risk assesment if needed?
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Environmental monitoring plan:
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One month monitoring record:
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1.1.5 Is a ISO9001 self-assessment conducted at appropriate intervals, at least quarterly, by a cross-functional team?
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ISO9001 self-assessment record:
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1.1.6 Is there an effective system in place to ensure the product has completed validation and stability testing, and obtained approval from the MFDS (Ministry of Food and Drug Safety)?
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Product validation test reoort and approval letter from MFDS:
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1.1.7 Does the factory have a quality manual that ensures compliance with the Pharmaceutical Affairs Act and related ISO9001 regulations? Are quality measurable objectives established, maintained and reviewed and distributed to different department?
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Quality manual and reviewed records:
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1.1.8 The product label should contain the following information: - Product Name - Active Ingredient(s) and their strength/concentration - Dosage Form (e.g., tablet, injection, ointment) - Indications or intended use - Dosage and Administration Instructions - Warnings and Precautions - Storage Conditions -Expiration Date and Manufacturing Date - Batch or Lot Number - Manufacturer’s Name and Address - Approval Number issued by the MFDS (Ministry of Food and Drug Safety) - Contraindications and Side Effects - Instructions for Use (if applicable) - Country of Origin (for imported medicines)
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Merge all product labels of Coupang into one file:
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Section 2 On Boarding Document
1.2.1 Technical Documentation
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Technical Documentation:
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1.2.2 Final Test Report
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Final Test Report:
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1.2.3 Advertisement Review Certificate
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Advertisement Review Certificate:
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1.2.4 Standard Customs Clearance Report
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Standard Customs Clearance Report:
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1.2.5 Medical Device Labeling Checklist
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Medical Device Labeling Checklist:
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1.2.6 Supporting Documents for Medical Device Product Approval/Notification
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Supporting Documents for Medical Device Product Approval/Notification:
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