Resolution 549, 30 August 2021. Language: Portuguese. Number of Pages: 3. http://antigo.anvisa.gov.br/documents/10181/6319486/RDC_549_2021_.pdf/7005e09d-b4de-404c-b0a3-3e4e03cea323

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Distribution date: 14 September 2021

This resolution disposes about the procedures for compulsory certification of equipment under the Sanitary Surveillance regime.

Products Covered: HS (3006) – equipment under the Sanitary Surveillance regime.

Regulation Type: Regular notification

Resolution 544, 30 August 2021. Language: Portuguese. Number of Pages: 16. http://antigo.anvisa.gov.br/documents/10181/6319629/RDC_544_2021_.pdf/6cc084e7-51f7-42e6-99cb-028311b420aa

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Distribution date: 14 September 2021

This resolution disposes about plastic bags for the collection, storage and transfer of human blood and its components.

Products Covered: HS (3002, 3006) - plastic bags for the collection, storage and transfer of human blood and its components

Regulation Type: Regular notification

Normative Instruction number 101, 30 August 2021. http://antigo.anvisa.gov.br/documents/10181/6319486/IN_101_2021_.pdf/0625051c-003d-41f9-aca5-1ce5724b76d8

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Distribution date: 14 September 2021

This resolution establishes specific criteria for grouping materials for health use into families for market authorization and notification purposes.

Products Covered: HS (3001-3006) - grouping materials for health use

Regulation Type: Regular notification

Resolution 541, 30 August 2021. Language: Portuguese. Number of Pages: 6. http://antigo.anvisa.gov.br/documents/10181/6319545/RDC_541_2021_.pdf/d70b9457-dbf5-4ca7-a535-61f7461e4cfd

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Distribution date: 14 September 2021

This resolution establishes minimum identity and quality requirements for single-use sterile hypodermic syringes.

Products Covered: HS (3006) - sterile hypodermic syringes

Regulation Type: Regular notification

DUS 2413:2021, Standard Test Method for Percent Ash Content of Engine Coolants, First Edition

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Distribution date: 14 September 2021 | Final date for Comment: 13 November 2021

This Draft Uganda Standard covers the determination of ash content after ignition of commercial engine coolants and antirusts, as packaged or after use.

Products Covered: Engine Coolants

Regulation Type: Regular notification

Resolution 550, 30 August 2021. Language: Portuguese. Number of Pages: 5. http://antigo.anvisa.gov.br/documents/10181/6319486/RDC_550_2021_.pdf/0e2ea0c1-ed5c-4356-a8c8-0c7fdaa7a1dc

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Distribution date: 14 September 2021

This resolution establishes the minimum identity and quality requirements for breast implants and the product conformity certification requirement under the Brazilian System of Conformity Assessment (BSCA).

Products Covered: HS (3006) - breast implants

Regulation Type: Regular notification

DUS 2432:2021, Standard Test Method for Density or Relative Density of Engine Coolant Concentrates and Engine Coolants By The Hydrometer, First Edition

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Distribution date: 14 September 2021 | Final date for Comment: 13 November 2021

This Draft Uganda Standard covers the determination of the relative density of glycols, glycerin, heat transfer fluids, engine coolant concentrates, and aqueous engine coolants

Products Covered: Anti-freezing preparations and prepared de-icing fluids (excl. prepared additives for mineral oils or other liquids used for the same purposes as mineral oils) (HS code(s): 3820); Refrigerants and antifreezes (ICS code(s): 71.100.45)

Regulation Type: Regular notification

DUS 2408: 2021, Standard Test Method for Color of Clear Liquids (Platinum-Cobalt Scale), First Edition

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Distribution date: 14 September 2021 | Final date for Comment: 13 November 2021

This Draft Uganda Standard describes a procedure for the visual measurement of the color of essentially light colored liquids. It is applicable only to materials in which the color-producing bodies present have light absorption characteristics nearly identical with those of the platinum-cobalt color standards used.

Products Covered: Paints, Varnishes

Regulation Type: Regular notification

DUS 706:2021, Non-woven surgical dressing — Specification, Second Edition

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Distribution date: 14 September 2021 | Final date for Comment: 13 November 2021

This Draft Uganda Standard specifies the requirements, sampling and methods of test for three types of non-woven surgical dressings; unpadded swabs, padded swabs and surgical pads

Products Covered: Non-woven surgical dressing

Regulation Type: Regular notification

DUS 2409:2021, Standard Test Method for Iron in Trace Quantities Using the 1,10-Phenanthroline Method, First Edition

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Distribution date: 14 September 2021 | Final date for Comment: 13 November 2021

This Draft Uganda Standard covers the determination of iron in the range from 1 to 100 μg.

Products Covered: Iron

Regulation Type: Regular notification

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