Partial amendment to the Ministerial Order for the Standard of Manufacturing Control and Quality Control for Medical Devices and In vitro Diagnostics Pharmaceutical Products.
Distribution date: 17 November 2020 | Final date for Comment: 16 January 2021
The Ministerial Order for the Standard of Manufacturing Control and Quality Control for Medical Devices and In vitro Diagnostic Pharmaceutical Products will be amended to harmonize with the amended relevant international standard (ISO 13485).
Products Covered: In vitro Diagnostic Pharmaceutical Products (HS: 30). Medical Devices (HS: 90).
Regulation Type: Regular notification
Partial amendment to the Ministerial Order for the Standard of Manufacturing Control and Quality Control for Medical Devices and In vitro Diagnostics Pharmaceutical Products.
Distribution date: 17 November 2020 | Final date for Comment: 16 January 2021
The Ministerial Order for the Standard of Manufacturing Control and Quality Control for Medical Devices and In vitro Diagnostic Pharmaceutical Products will be amended to harmonize with the amended relevant international standard (ISO 13485).
Products Covered: In vitro Diagnostic Pharmaceutical Products (HS: 30). Medical Devices (HS: 90).
Regulation Type: Regular notification
Resolution - RDC number 436, 5 November 2020
Distribution date: 17 November 2020
The Resolution - RDC number 428, 7 October 2020 - previously notified through G/SPS/N/BRA/1788 - which changes the Resolution - RDC number 177, 21 September 2017, which provides for the ban on the active ingredient Paraquat in pesticides in the country and for transitional risk mitigation measures; and regulates the application of the stocks of the active ingredient Paraquat based products under possession of the Brazilian farmers in the crops management of the agricultural harvest of 2020/2021, was changed by the Resolution - RDC number 436, 5 November 2020. This regulation will be also notified to the TBT committee.The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6053710/RDC_436_2020_.pdf/b36028dd-b15a-4f6a-97d9-4b90a337cdac
Products Covered:
Regulation Type: Addendum to Regular Notification
Resolution - RDC number 436, 5 November 2020
Distribution date: 17 November 2020
The Resolution - RDC number 428, 7 October 2020 - previously notified through G/SPS/N/BRA/1788 - which changes the Resolution - RDC number 177, 21 September 2017, which provides for the ban on the active ingredient Paraquat in pesticides in the country and for transitional risk mitigation measures; and regulates the application of the stocks of the active ingredient Paraquat based products under possession of the Brazilian farmers in the crops management of the agricultural harvest of 2020/2021, was changed by the Resolution - RDC number 436, 5 November 2020. This regulation will be also notified to the TBT committee.The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6053710/RDC_436_2020_.pdf/b36028dd-b15a-4f6a-97d9-4b90a337cdac
Products Covered:
Regulation Type: Addendum to Regular Notification
Amendment of “Standards of In-Vitro Diagnostic Medical Devices Good Manufacturing Practices”
Distribution date: 17 November 2020 | Final date for Comment: 16 January 2021
Ministry of Food and Drug Safety of Republic of Korea is proposing to amend the “Standards of In-Vitro Diagnostic Medical Devices Good Manufacturing Practices”. The main changes proposed are: For IVD GMP audits that are subject to documentation review only, there are two additional documents that are required to be submitted.
Products Covered: In-Vitro Diagnostic Medical Devices
Regulation Type: Regular notification
Amendment of “Standards of In-Vitro Diagnostic Medical Devices Good Manufacturing Practices”
Distribution date: 17 November 2020 | Final date for Comment: 16 January 2021
Ministry of Food and Drug Safety of Republic of Korea is proposing to amend the “Standards of In-Vitro Diagnostic Medical Devices Good Manufacturing Practices”. The main changes proposed are: For IVD GMP audits that are subject to documentation review only, there are two additional documents that are required to be submitted.
Products Covered: In-Vitro Diagnostic Medical Devices
Regulation Type: Regular notification
Resolution - RE number 4447, 29 October 2020
Distribution date: 16 November 2020
The Draft Resolution number 883, 23 July 2020 - previously notified through G/SPS/N/BRA/1745 - was adopted as Resolution - RE number 4447, 29 October 2020. The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=03/11/2020&jornal=515&pagina=556
Products Covered:
Regulation Type: Addendum to Regular Notification
Resolution - RE number 4447, 29 October 2020
Distribution date: 16 November 2020
The Draft Resolution number 883, 23 July 2020 - previously notified through G/SPS/N/BRA/1745 - was adopted as Resolution - RE number 4447, 29 October 2020. The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=03/11/2020&jornal=515&pagina=556
Products Covered:
Regulation Type: Addendum to Regular Notification
Methylene Chloride (Dichloromethane) (Quality Control) Order, 2020
Distribution date: 16 November 2020 | Final date for Comment: 15 January 2021
Methylene Chloride (Dichloromethane) finds application in the manufacturing of Pharmaceuticals, agro chemicals, photographic films etc. Monitoring of purity 99.5% and Heavy Metal content max one PPM warrants making the standard mandatory.Since this item goes to Pharma sector, its quality need to conform to the BIS standards otherwise impurities of Methylene Chloride may enter the animal & human chain. So, for protection of human health, the standard needs to be made mandatory. The locally manufactured or imported Methylene Chloride (Dichloromethane) shall conform to the Indian standard (IS 4566:2020) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS). The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority.
Products Covered: Methylene Chloride (Dichloromethane) (HS Code 29031200)
Regulation Type: Regular notification
Methylene Chloride (Dichloromethane) (Quality Control) Order, 2020
Distribution date: 16 November 2020 | Final date for Comment: 15 January 2021
Methylene Chloride (Dichloromethane) finds application in the manufacturing of Pharmaceuticals, agro chemicals, photographic films etc. Monitoring of purity 99.5% and Heavy Metal content max one PPM warrants making the standard mandatory.Since this item goes to Pharma sector, its quality need to conform to the BIS standards otherwise impurities of Methylene Chloride may enter the animal & human chain. So, for protection of human health, the standard needs to be made mandatory. The locally manufactured or imported Methylene Chloride (Dichloromethane) shall conform to the Indian standard (IS 4566:2020) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS). The use of standard mark is governed by the provisions of Bureau of Indian Standards Act 1986 and the Rules and Regulations made there under. Bureau of Indian Standards shall be the certifying and enforcing authority.
Products Covered: Methylene Chloride (Dichloromethane) (HS Code 29031200)
Regulation Type: Regular notification
Submit your email ID to receive notifications about upcoming courses and events
