Proyecto de Reglamento que Regula los Cambios en el Registro Sanitario de los Dispositivos Médicos (Draft Regulation governing changes to medical devices in the sanitary register) (5 pages, in Spanish)
Distribution date: 02 July 2020 | Final date for Comment: 30 August 2020
The notified draft Regulation provides for major and minor changes in the sanitary register, as they may have repercussions on the quality, safety and effectiveness of medical devices, and establishes the conditions and documents required for such changes.
Products Covered: Medical devices; Glands and other organs for organo-therapeutic uses, dried, whether or not powdered; extracts of glands or other organs or of their secretions for organo-therapeutic uses; heparin and its salts; other human or animal substances prepared for therapeutic or prophylactic uses, not elsewhere specified or included (HS 3001); Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms and similar products (excluding yeasts).(HS 3002); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale (HS 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale (HS 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes (HS 3005); Pharmaceutical goods specified in Note 4 to Chapter 30 and included in subheadings 3006.10.10 to 3006.60.90 (HS 3006)
Regulation Type: Regular notification
The Resolution – RDC no. 301, 21 August 2019 – previously notified through G/TBT/N/BRA/870 – which adopts the Guide to Good Manufacturing Practices for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was altered by Resolution – RDC no. 388, 26 May 2020, and was published in the Brazilian Official Gazette no. 101, on 28 May 2020, section 1, page 62. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 03 July 2020 | Final date for Comment: 14 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Resolution – RDC no. 301, 21 August 2019 – previously notified through G/TBT/N/BRA/870 – which adopts the Guide to Good Manufacturing Practices for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was altered by Resolution – RDC no. 388, 26 May 2020, and was published in the Brazilian Official Gazette no. 101, on 28 May 2020, section 1, page 62. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 03 July 2020 | Final date for Comment: 14 May 2025
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
Styrene (Vinyl Benzene) (Quality Control) Order, 2020
Distribution date: 06 July 2020 | Final date for Comment: 04 September 2020
This order seeks to ensure conformity to Styrene (Vinyl Benzene) (Quality Control) Order, 2020 listed in the schedule to the specified Indian Standard.
Products Covered: IS 4105:2020; Styrene (Vinyl Benzene) (HS code 29025000).
Regulation Type: Regular notification
Styrene (Vinyl Benzene) (Quality Control) Order, 2020
Distribution date: 06 July 2020 | Final date for Comment: 04 September 2020
This order seeks to ensure conformity to Styrene (Vinyl Benzene) (Quality Control) Order, 2020 listed in the schedule to the specified Indian Standard.
Products Covered: IS 4105:2020; Styrene (Vinyl Benzene) (HS code 29025000).
Regulation Type: Regular notification
Vinyl Acetate Monomer (Quality Control) Order, 2020
Distribution date: 06 July 2020 | Final date for Comment: 04 September 2020
This order seeks to ensure conformity to Vinyl Acetate Monomer (Quality Control) Order, 2020 listed in the schedule to the specified Indian Standard.
Products Covered: IS 12345:1988 - Vinyl Acetate Monomer (HS Code 29153200)
Regulation Type: Regular notification
Vinyl Acetate Monomer (Quality Control) Order, 2020
Distribution date: 06 July 2020 | Final date for Comment: 04 September 2020
This order seeks to ensure conformity to Vinyl Acetate Monomer (Quality Control) Order, 2020 listed in the schedule to the specified Indian Standard.
Products Covered: IS 12345:1988 - Vinyl Acetate Monomer (HS Code 29153200)
Regulation Type: Regular notification
Acrylonitrile (Quality Control) Control, 2020
Distribution date: 07 July 2020 | Final date for Comment: 05 September 2020
This order seeks to ensure conformity to Acrylonitrile listed in the schedule to the specified Indian Standard.
Products Covered: IS 12540:1988 Acrylonitrile (HS code 29261000)
Regulation Type: Regular notification
Acrylonitrile (Quality Control) Control, 2020
Distribution date: 07 July 2020 | Final date for Comment: 05 September 2020
This order seeks to ensure conformity to Acrylonitrile listed in the schedule to the specified Indian Standard.
Products Covered: IS 12540:1988 Acrylonitrile (HS code 29261000)
Regulation Type: Regular notification
Maleic Anhydride (Quality Control) Order, 2020
Distribution date: 07 July 2020 | Final date for Comment: 05 September 2020
This order seeks to ensure conformity to Maleic Anhydride (Quality Control) Order, 2020 listed in the schedule to the specified Indian Standard.
Products Covered: Maleic Anhydride (HS code 29171400); IS 5149:2020
Regulation Type: Regular notification
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