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Pending listing

Here you can see for each of your new listing submissions , the pending items to clear before enter our market place in either EU or Japan market

sterilized gloves

submission date : 2025-06-01

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Disposable Anesthesia Breathing Circuit

submission date: 2025-06-01

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sterilized gloves 

once uploaded & verified  , the items will be marked as completed 

Pending Documents – European Union (EU MDR)

  1. CE Declaration of Conformity
    Missing — must include reference to MDR 2017/745, Class Is classification.

  2. Sterilization Validation Report (ISO 11135)
    Required to confirm EO/gamma process meets EU safety standards.

  3. Technical File (Complete)
    Pending full submission — must include risk analysis, clinical evaluation summary, and product labeling samples.

  4. UDI Registration Confirmation
    Unique Device Identifier must be registered in EUDAMED system.

  5. Authorized Representative Agreement
    Not yet signed — required if manufacturer is outside the EU.

Pending Documents – Japan (PMDA)

  1. Foreign Manufacturer Accreditation (FMA)
    Missing — must be obtained from MHLW prior to registration.

  2. Japanese-Language Product Specification Sheet
    Required — not yet uploaded in local format.

  3. GMP Certificate (issued by domestic authority)
    Needed to demonstrate quality control at manufacturing site.

  4. MAH (Marketing Authorization Holder) Contract
    Not yet finalized — required to appoint local legal entity for import and distribution.

  5. Sterilization Process Validation (JP Pharmacopoeia compliant)
    Technical document needed to confirm conformity with Japanese standards.

Disposable Anesthesia Breathing Circuit

once uploaded & verified  , the items will be marked as completed 

Pending Documents-European Union (EU MDR)

  1. CE Declaration of Conformity
    Not yet submitted — must reference MDR 2017/745 for Class IIa devices.

  2. Clinical Evaluation Report (CER)
    Required for risk/benefit assessment of breathing interface use in surgical procedures.

  3. ISO 5356 Connector Conformity Certificate
    Needed to confirm circuit compatibility with standard ventilator and mask fittings.

  4. Packaging Validation Report
    Missing — required to ensure sterility integrity during transportation and shelf life.

  5. EUDAMED UDI Registration
    Product not yet registered in the Unique Device Identifier database.

Pending Documents-Japan (PMDA)

  1. Foreign Manufacturer Accreditation (FMA)
    Application not submitted — essential for all imported Class II devices.

  2. Sterilization Process Flow & Validation Report (JP standard)
    Missing EO/gamma protocol data in compliance with Japanese pharmacopoeia.

  3. Material Safety Data Sheet (MSDS) – JP format
    Required for all plastics/silicone components used in respiratory circuits.

  4. MAH Contract & Label Review
    Local Marketing Authorization Holder not yet assigned; label translation pending approval.

  5. Device Description Form (Shonin)
    PMDA registration form partially incomplete — product use case and diagram sections missing.

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