Distribution date: 02 September 2020 | Final date for Comment: 05 October 2020

This draft normative instruction establishes technical requirements for medical devices selected to economic monitoring by Anvisa. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=58342

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 02 September 2020 | Final date for Comment: 16 October 2020

This draft resolution establishes the shared production areas destined for the manufacturing of personal hygiene products, cosmetics, and perfumes of human use and for the manufacturing of veterinary hygiene and beauty products. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=58997

Products Covered: 340130; 9619

Regulation Type: Regular notification

Distribution date: 02 September 2020 | Final date for Comment: 16 October 2020

This draft resolution establishes the shared production areas destined for the manufacturing of personal hygiene products, cosmetics, and perfumes of human use and for the manufacturing of veterinary hygiene and beauty products. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=58997

Products Covered: 340130; 9619

Regulation Type: Regular notification

Distribution date: 02 September 2020 | Final date for Comment: 05 October 2020

This draft resolution establishes the economic monitoring for medical devices. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=58342

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 02 September 2020 | Final date for Comment: 05 October 2020

This draft resolution establishes the economic monitoring for medical devices. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=58342

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 02 September 2020 | Final date for Comment: 05 October 2020

This draft normative instruction establishes the list of medical devices selected to economic monitoring by Anvisa. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=58342

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 02 September 2020 | Final date for Comment: 05 October 2020

This draft normative instruction establishes the list of medical devices selected to economic monitoring by Anvisa. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=58342

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 02 September 2020 | Final date for Comment: 26 October 2020

This draft resolution establishes technical requirements for the inclusion or alteration of substances in the list of preservatives that are allowed in the manufacturing of sanitizing products. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=58220

Products Covered: 340119

Regulation Type: Regular notification

Distribution date: 02 September 2020 | Final date for Comment: 26 October 2020

This draft resolution establishes technical requirements for the inclusion or alteration of substances in the list of preservatives that are allowed in the manufacturing of sanitizing products. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=58220

Products Covered: 340119

Regulation Type: Regular notification

Distribution date: 01 September 2020 | Final date for Comment: 31 October 2020

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is partly revising the “Regulation on Substantiation of Claims in Labeling or Advertising of Cosmetic Products” (Public Notice issued by the MFDS) as the following: ­ – This Public Notice aims to stipulate the documentation of side effects and the treatments for the side effects in the substantiation of claims in cosmetic labelling or advertising compensation. ­– Even before the revision, responsible cosmetic distribution businesses were required to obtain informed consents from test subjects in written form in order to substantiate the advertised claims. The regulation has set forth that the consent documents should provide potential side effects observed in subjects, treatments for side effects and compensations available in case of injury, among others. Thus, the obligation to substantiate matters related to the treatment of side effects and compensations for subjects remains the same as before. – The revision does not impose any new obligation to treat side effects or provide compensation, but simply prescribes that the documentation of side effects is necessary.

Products Covered: Cosmetics

Regulation Type: Regular notification