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A Compilation of Worldwide Regulatory Requirements
for
Exporting Dental and Medical Products to Industrialized Nations
From the DTA Export Committee
Costa Rica, Guatemala, Panama, Argentina, Brazil, Chile, Colombia, Peru, Venezuela, & Mexico:
http://www.ita.doc.gov/td/health/ then click on "Foreign Regulations"
Europe:
http://mdss.com/articles/article_3.htm
Australia:
http://www.tga.gov.au/docs/html/dentalreg.htm
Middle East & North Africa:
http://web.ita.doc.gov/ticwebsite/meweb.nsf
China, Korea, Japan:
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Required Docs |
Product 1 |
Product 2 |
Product 3 |
Product 4 |
Product 5 |
| 1 |
General information |
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| 2 |
Raw Material description |
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| 3 |
Raw Material spec sheet |
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| 4 |
MSDS |
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| 5 |
Test report for physical properties |
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| 6 |
Test report for shelf-life |
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| 7 |
Packing information |
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| 8 |
Clinical research or biological safety report |
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* Remarks |
| 1 |
General information |
User's manual, catalogue, brochure for usage, caution, storage, etc. |
| 2 |
Raw Material description |
Show CAS numbers or any other material standard numbers for each material (even for pigments). Show weight % making up 100% exactly. |
| 3 |
Raw Material spec sheet |
Make specification sheet for each raw material
respectively showing its brief physical or chemical features. It means, for example, if there are
10 raw materials used for a product, there should be 10 different specification sheets.
1 page will be enough for each specification sheet. |
| 4 |
MSDS |
Send us MSDS for product |
| 5 |
Test report for physical properties |
It is essentially recommended for you to
refer to the relevant ISO standard first so that you can learn which physical properties should be tested.
For example, in case of polymer based restorative materials(dual cure), as it is classified as
ISO 4049, type 2, class 3, your testing report should show every physical property which is described
in that standard.
Testing report should meet the following requirements.
a. Testing sample- 3 samples should be tested.
b. Detailed testing method (procedure) -- refer to relevant ISO standard. If testing is
performed according to your own protocol, please describe it in as much detail as possible.
c. Testing result.
d. Approval date, signature and name of the person conducting the test.
***It will be very helpful if there are raw test data such as graphs, pictures etc.
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| 6 |
Test report for shelf-life |
This testing report is to prove the shelf
life of your product. It should have following contents (format).
a. Testing sample description
b. Testing method - Usually acceleration test is done for shelf life, as it is very difficult to test samples for all the time of its shelf life.
Acceleration test means the method of giving samples more severe conditions than usual with, for example, high temperature or pressure to test it in short time. If you have real time test data, it is also accepted.
c. Test results - Should be comparison data among different times of testing.
d. Approval date, signature and name of the person conducting the test.
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| 7 |
Packing information |
Packing method, Packing procedure, Packing materials |
| 8 |
Clinical research or biological safety report |
Any research data which is performed by an independent institution or carried in a dental academic magazine. |
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Regulatory