Distribution date: 01 July 2022 | Final date for Comment: 04 May 2025

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Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 06 July 2022 | Final date for Comment: 04 May 2025

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Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); HEALTH CARE TECHNOLOGY (ICS code(s): 11)

Regulation Type: Addendum to Regular Notification

Distribution date: 06 July 2022 | Final date for Comment: 04 May 2025

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Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); HEALTH CARE TECHNOLOGY (ICS code(s): 11)

Regulation Type: Addendum to Regular Notification

Distribution date: 11 July 2022 | Final date for Comment: 04 October 2022

The Draft amendments to the Rules of classification of medical devices depending on the potential risk of use apply to medical devices and provide for the following:clarification of the concepts; clarification of classification criteria for medical devices for in vitro diagnostics; establishment of criteria and conditions for the classification of software that is a medical device; clarification of classification of medical devices.

Products Covered: 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 code(s): 3005); Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments. (HS code(s): 9018); Apparatus based on the use of X-rays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus, X-ray tubes and other X-ray generators, high tension generators, control panels and desks, screens, examination or treatment tables, chairs and the like. (HS code(s): 9022); Medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical fittings, dentists' chairs); barbers' chairs and similar chairs, having rotating as well as both reclining and elevating movements; parts of the foregoing articles. (HS code(s): 9402)

Regulation Type: Regular notification

Distribution date: 11 July 2022 | Final date for Comment: 04 October 2022

The Draft amendments to the Rules of classification of medical devices depending on the potential risk of use apply to medical devices and provide for the following:clarification of the concepts; clarification of classification criteria for medical devices for in vitro diagnostics; establishment of criteria and conditions for the classification of software that is a medical device; clarification of classification of medical devices.

Products Covered: 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 code(s): 3005); Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments. (HS code(s): 9018); Apparatus based on the use of X-rays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus, X-ray tubes and other X-ray generators, high tension generators, control panels and desks, screens, examination or treatment tables, chairs and the like. (HS code(s): 9022); Medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical fittings, dentists' chairs); barbers' chairs and similar chairs, having rotating as well as both reclining and elevating movements; parts of the foregoing articles. (HS code(s): 9402)

Regulation Type: Regular notification

Distribution date: 12 July 2022 | Final date for Comment: 10 September 2022

The Regulations require performance certification on select monitoring or measuring instruments that are not subject to type approval or preliminary type approval under the Environmental Testing and Inspection Act (hereinafter referred to as “simple measuring instruments”). Under the Act, no person shall manufacture or import simple measuring instruments without the performance certification, and the Regulations prescribe a two-level certification system (Grade 1 and Certified) for these instruments.Specifically, the Regulations prescribe the list of simple measuring instruments, the process and required documents for applying performance certification, and the threshold for performance certification by medium (air, water, noise, etc.).

Products Covered: 9027-10-0000 (Gas or smoke analysis apparatus),9027-30-4000 (spectrometers),9027-50-3000 (colorimeters),9027-90-9099 (other)

Regulation Type: Regular notification

Distribution date: 12 July 2022 | Final date for Comment: 10 September 2022

The Regulations require performance certification on select monitoring or measuring instruments that are not subject to type approval or preliminary type approval under the Environmental Testing and Inspection Act (hereinafter referred to as “simple measuring instruments”). Under the Act, no person shall manufacture or import simple measuring instruments without the performance certification, and the Regulations prescribe a two-level certification system (Grade 1 and Certified) for these instruments.Specifically, the Regulations prescribe the list of simple measuring instruments, the process and required documents for applying performance certification, and the threshold for performance certification by medium (air, water, noise, etc.).

Products Covered: 9027-10-0000 (Gas or smoke analysis apparatus),9027-30-4000 (spectrometers),9027-50-3000 (colorimeters),9027-90-9099 (other)

Regulation Type: Regular notification

Distribution date: 12 July 2022 | Final date for Comment: 11 August 2022

The Minimum Requirements for Biological Products will be amended as follows；To add the standard, criterion, fee and quantity for a vaccine product to be newly approved; “Meningococcal tetravalent polysaccharide tetanus toxoid conjugate vaccine”, “Pneumococcal 15-valent conjugate vaccine”. Partially amended to “Meningococcal tetravalent polysaccharide diphtheria toxoid conjugate vaccine”, “Pneumococcal Vaccine Polyvalent”, “Pneumococcal 13-valent conjugate vaccine”, “Smallpox Vaccine Prepared in Cell Culture”, “Freeze-dried Smallpox Vaccine Prepared in Cell Culture”. To delete “Pneumococcal 10-valent conjugate vaccine”, “Smallpox Vaccine”, “Freeze-dried Smallpox Vaccine”.The Public Notice on National Release Testing will be amended as follows； To add the criterion, fee and quantity for a vaccine product to be newly approved; “Meningococcal tetravalent polysaccharide tetanus toxoid conjugate vaccine”, “Pneumococcal 15-valent conjugate vaccine”. Partially amended to “Meningococcal tetravalent polysaccharide diphtheria toxoid conjugate vaccine”, “Pneumococcal Vaccine Polyvalent”, “Pneumococcal 13-valent conjugate vaccine”, “Smallpox Vaccine Prepared in Cell Culture”, “Freeze-dried Smallpox Vaccine Prepared in Cell Culture”. To delete “Pneumococcal 10-valent conjugate vaccine”, “Smallpox Vaccine”, “Freeze-dried Smallpox Vaccine”.

Products Covered: Pharmaceutical products (HS code(s): 30)

Regulation Type: Regular notification

Distribution date: 12 July 2022 | Final date for Comment: 11 August 2022

The Minimum Requirements for Biological Products will be amended as follows；To add the standard, criterion, fee and quantity for a vaccine product to be newly approved; “Meningococcal tetravalent polysaccharide tetanus toxoid conjugate vaccine”, “Pneumococcal 15-valent conjugate vaccine”. Partially amended to “Meningococcal tetravalent polysaccharide diphtheria toxoid conjugate vaccine”, “Pneumococcal Vaccine Polyvalent”, “Pneumococcal 13-valent conjugate vaccine”, “Smallpox Vaccine Prepared in Cell Culture”, “Freeze-dried Smallpox Vaccine Prepared in Cell Culture”. To delete “Pneumococcal 10-valent conjugate vaccine”, “Smallpox Vaccine”, “Freeze-dried Smallpox Vaccine”.The Public Notice on National Release Testing will be amended as follows； To add the criterion, fee and quantity for a vaccine product to be newly approved; “Meningococcal tetravalent polysaccharide tetanus toxoid conjugate vaccine”, “Pneumococcal 15-valent conjugate vaccine”. Partially amended to “Meningococcal tetravalent polysaccharide diphtheria toxoid conjugate vaccine”, “Pneumococcal Vaccine Polyvalent”, “Pneumococcal 13-valent conjugate vaccine”, “Smallpox Vaccine Prepared in Cell Culture”, “Freeze-dried Smallpox Vaccine Prepared in Cell Culture”. To delete “Pneumococcal 10-valent conjugate vaccine”, “Smallpox Vaccine”, “Freeze-dried Smallpox Vaccine”.

Products Covered: Pharmaceutical products (HS code(s): 30)

Regulation Type: Regular notification

Distribution date: 12 July 2022 | Final date for Comment: 04 May 2025

This Resolution contains provisions on products for amateur gardening and their marketing authorization.  

Products Covered: ENVIRONMENT. HEALTH PROTECTION. SAFETY (ICS code(s): 13) - Gardening products

Regulation Type: Regular notification