Regulatory Updates
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
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
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
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
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
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
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
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
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
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
DUS 2407:2021, Standard Test Methods for Analysis of Ethylene Glycols and Propylene Glycols, First Edition
Distribution date: 14 September 2021 | Final date for Comment: 13 November 2021
This Draft Uganda Standard covers the chemical and physical analysis of the commonly available grades of ethylene glycol, diethylene glycol, triethylene glycol, propylene glycol, and dipropylene glycol.
Products Covered: Ethylene Glycols, Propylene Glycols
Regulation Type: Regular notification
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