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Water-based gel lubricants registeration supporting documents

The lubricant gel in some country still taken as medical device, so the gel's sell still need registeration at authority to get the license, this process will need samples and the supporting documents as following, this is one example from one EU country, so our clients only can refer it accordingly, as each country always has their own rules, so we'd better inquiry them directly and ask them the file list, and then we prepare accordingly is the regith way:

1.            Price FCA nearest international seaport and airport palletized

2.            Product references

3.            Brochure / product data sheet

4.            User manual of each offered items (if applicable)

5.            Confirmation of compliance to requested specifications or stating deviations if any in the attached specification form

6.            ISO 13485 - if available

7.            ISO 9001 - if available

8.            EC certificate and Declaration of Conformity (DoC) (alternatively FDA registration or equivalent e.g. from Canada, Japan, or Australia)

9.            Copy of valid manufacturing license

10.         Packaging photos of primary and secondary packaging with legible labelling as per regulations as per e.g. MDR/IVDR.

11.         Unique Device Identifier (UDI), as applicable

12.         Post-market surveillance procedures (may be requested by client)

13.         Safety Datasheet (SDS) for DGR items (if applicable)

14.         Certificate of Analysis (CoA))

15.         Certificate of sterilization (for sterile items)

16.         Transportation & storage restrictions (e.g. temperature ranges, cold chain, hazardous, only air, only sea, not put on side etc.)

17.         Product shelf life (if applicable). Upon award, fresh products should be supplied e.g. with minimum 85% shelf life.

18.         Delivery time

19.         Warranty time

20.         Payment conditions

21.         Estimated transport volume (cbm) & gross weight (kg)

22.         HS Code 3006700000

Get import and sell license is important for lubricating gel's project, you need serious in each steps and prepare it exactly as the requested, welcome contact us if you need any help in the files, as we already successfully registered at more than 100 countries, so we are familiar with the rules and requirements.


Name: Shandong Ming Yuan Latex Co.,Ltd





Add:Shandong Province,People Republic of China

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