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Colombia Standards: Dental Products

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Colombia Standards: Dental Products

Postby bridgat » Tue Nov 18, 2008 4:21 am

The import of dental materials is subject to the issuance of a sanitary registration by the INSTITUTO NACIONAL DE CONTROL DE ALIMENTOS Y MEDICAMENTOS - INVIMA (National Institute for Medications and Food Surveillance). The following are general procedure guidelines for obtaining the registration.

Colombian regulations consider that dental materials are (a) those used in the buccal cavity momentarily, temporarily, or permanently to prevent, alleviate, repair, correct, or modify altered tissues or replace lost organs and (b) materials used in dental laboratories for prosthesis elaboration.

Products used for dental care, but with specific pharmacological effect(s), are to be registered as medications.

The following dental materials require sanitary registration:

Molding materials:
Asbestos rolls.
Waxes for dental use.
Prosthesis coatings used by dental laboratories.
Plaster dental type 1, 2, 3, and 4
Impression materials:
Dental cement
Zinc oxide based paste, with or without eugenol
High, medium and low fusion molding compound
Mercaptans
Silicones
Alginates
Reversible and non-reversible Hydrochloride
Materials for temporary and permanent restoration
Filling plastic materials
Filling metal alloys
Casted alloys of precious and similar metals for dental use
Three-distillated mercury
Materials for radicular channel filling
Gutta-percha for dental use
Denture materials:
Casted chrome/cobalt alloys for dental use
Denture base polymers
Autocure resins

SANITARY REGISTRATION SPECIAL REQUIREMENTS

The sanitary registration application form must be submitted along with the product technical information in duplicate and in the Spanish language. Components quantities must be given in metric system units or in International Measuring System units, as applicable. The technical information must be signed by the person responsible for the manufacturing process and must include:
Product name.
Owner's name.
Manufacturer's name, explaining if the manufacturer is the owner or if the product is manufactured under license.
Purpose of the sanitary registration: either to manufacture and sell or to import and sell.
Information on the product's commercial presentation.
Product quantitative composition, listing all the components with generic and chemical names.
Description of the elaboration process.
Quantity and use instructions.
Applications, contraindications, and precautions.
Product stability and validity period under normal conditions.
Qualitative and quantitative identification method of the components of the finished product formula.
Quality control tests undergone by the finished product, indicating their values or ranges.

MULTIPLE COVERAGE

One sanitary registration may cover several dental materials when:

They have the same chemical and qualitative composition and differ only on aspects such as size, consistency, color, and presentation.
Those that belong to the same group with variations in their physical characteristics such as cast (type 1, 2, 3, or 4), molding compound (high, medium, or low fusion), silicones, alginates, etc.

LABELING REQUIREMENTS

Labels, wrappings, bags, or boxes in which dental materials are packed must be previously approved and have the following printed information :
Product name.
Manufacturer's name and domicile.
Content
Product composition with quantitative specifications of the components' concentration.
Batch code or number used to identify units manufactured during the same cycle and with the same raw materials.
The sanitary registration number.
Other captions, figures, or images the importer/manufacturer wants to include.
bridgat
 
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