Regulatory Updates

Distribution date: 21 February 2020 | Final date for Comment: 20 April 2020

The Draft amendments to the Rules for registration and examination of safety, quality and effectiveness of medical devices apply to medical devices issued for circulation in the territory of the Eurasian economic union and provide for the following: - clarification of terms and definitions;- clarification of the mechanism for implementing the procedure for approval by States of the recognition of the expert opinion of the reference state;- determination of cases when changes are made to the registration dossier of medical devices in the notification procedure;- clarification of the procedure for canceling the validity (cancellation) of the registration certificate of a medical device.

Products Covered: Wadding, gauze, bandages (dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or in forms or packings for retail sale, for medical, surgical or veterinary use (HS 3005); Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight testing instruments (HS 9018); X-ray, alpha, beta, gamma radiation apparatus; x-ray tubes, x-ray generators, high tension generators, control panels and desks, screens, examination or treatm ent tables, chairs and the like (HS 9022); Furniture; medical, surgical, dental or veterinary (e.g. operating tables, hospital beds, dentists' chairs) barbers' chairs; parts (HS 9402).

Regulation Type: Regular notification

Distribution date: 21 February 2020 | Final date for Comment: 21 April 2020

This Uganda Standard specifies the requirements for steel sheet in coils and cut lengths for highstrength low-alloy steel (HSLA) supplied as hot-rolled sheet and cold-rolled sheet. For the purposes of determining conformance with this specification and the various material specifications, values shall be rounded to the nearest unit in the right-hand place of figures used in expressing the limiting values. For the purposes of determining conformance with this product specification, measured values, calculated values, or observed values shall be rounded to the nearest unit in the right hand place of figures used in expressing the limiting values.

Products Covered: Steel roofing sheets

Regulation Type: Regular notification

Distribution date: 17 February 2020 | Final date for Comment: 17 April 2020

The draft national technical regulation on wood paints and varnishes. Part 1. PU paints and varnishes (Polyurethane) specifies the technical and managerial requirements for wood paints and varnishes. Part 1. PU paints and varnishes (Polyurethane). This draft technical regulation does not apply to wood paints and varnishes which are used as testing samples, product samples, displaying samples, temporarily imported for exported and in transit. This draft technical regulation applies to: Domestic and foreign organizations, individuals manufacturing, processing, trading, exporting and importing food grade salt in the territory of Vietnam; State management agencies, concerned organizations and individuals. This draft technical regulation stipulates the responsibilities of organizations, individuals and implementing organizations of managing agencies.

Products Covered: Paints and varnishes, incl. enamels and lacquers, based on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in a non-aqueous medium; solutions of products of subheading 3901 to 3913 in volatile organic solvents, containing > 50% solvent by weight (excl. solutions of collodion) (HS code(s): 3208); Paints and varnishes (ICS code(s): 87.040)

Regulation Type: Regular notification

Distribution date: 17 February 2020 | Final date for Comment: 17 April 2020

The draft lifts certain veterinary measures applied to imported goods subject to veterinary control into the territory of the Eurasian Economic Union

Products Covered: Goods (products) subject to veterinary control (surveillance) and containing components of animal origin

Regulation Type: Regular notification

Distribution date: 17 February 2020 | Final date for Comment: 17 April 2020

Barium Carbonate is one of the important raw material widely used in the manufacture of different types of ceramic dielectric capacitors for high frequency application and for hard ferrites. The other important use is as an ingredient for the manufacture of ceramic glaze frits and fluxes, optical and ophthalmic glasses and special cut glasses. It is also used in other electro ceramic materials used a resistors, circuit breakers etc. The standard of Barium Carbonate for ceramic and glass industry prescribes minimum purity and impurity profile in maximum covering iron, sodium oxide and other metal sulphates etc. Barium Carbonate Technical is used for removing of sulfates in phosphoric acid production and chlorine alkali electrolysis. Barium Carbonate Technical is also used in the manufacture of various Barium compounds like Barium Chloride, Barium Nitrate, Barium Sulphide etc. The standards prescribe minimum content of Barium and Carbonate, besides impurity profile. The locally manufactured or imported Barium Carbonate shall conform to the Indian standard (IS 3205:1984, reaffirmed 2015 and IS 12928: 1990, reaffirmed 2017) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS). Bureau of Indian Standards of the State Governments shall be the enforcing authority.

Products Covered: Barium Carbonate (HS Code 2836 6000)

Regulation Type: Regular notification

Distribution date: 17 February 2020 | Final date for Comment: 17 April 2020

The draft national technical regulation on Wood Preservatives specifies the quality criteria and usage conditions for the water-borne wood preservatives. This draft technical regulation does not apply to wood preservatives which are testing samples, displaying samples, temporarily imported for exported and in transit.   This draft technical regulation applies to: Domestic and foreign organizations, individuals manufacturing, trading, exporting and importing water-borne wood preservatives in the territory of Vietnam. State management agencies, concerned organizations and individuals for the   quality of related products. Organizations auditing and declaring the conformity of water-borne wood preservatives products.  This draft national technical regulation stipulating responsibilities of organizations, individuals and implementing organizations of managing agencies.

Products Covered: Wood Preservative Products, compounds contain insecticide or fungicide contents (HS 38039910)

Regulation Type: Regular notification

Distribution date: 14 February 2020 | Final date for Comment: 14 April 2020

This East African Standard specifies the requirements for steel sheet in coils and cut lengths for high-strength low-alloy steel (HSLA) supplied as hot-rolled sheet and cold-rolled sheet. For the purposes of determining conformance with this specification and the various material specifications, values shall be rounded to the nearest unit in the right-hand place of figures used in expressing the limiting values. For the purposes of determining conformance with this product specification, measured values, calculated values, or observed values shall be rounded to the nearest unit in the right hand place of figures used in expressing the limiting values.

Products Covered: Flat-rolled products of iron or non-alloy steel, of a width >= 600 mm, hot-rolled, not clad, plated or coated (HS code(s): 7208); Flat-rolled products of iron or non-alloy steel, of a width >= 600 mm, hot-rolled, not clad, plated or coated (HS code(s): 7208); Iron and steel products (ICS code(s): 77.140)

Regulation Type: Regular notification

Distribution date: 14 February 2020 | Final date for Comment: 14 April 2020

This draft East African Standard specifies the requirements, sampling and test methods for hand and machine hacksaw blades.

Products Covered: Hand saws, with working parts of base metal (excl. power-operated saws); blades for saws of all kinds, incl. slitting, slotting or toothless saw blades, of base metal (HS code(s): 8202); Handsaws, with working parts of base metal (excl. power-operated saws); blades for saws of all kinds, incl. slitting, slotting or toothless saw blades, of base metal (HS code(s): 8202); Handsaws, with working parts of base metal (excl. power-operated saws) (HS code(s): 820210); Saws (ICS code(s): 25.100.40)

Regulation Type: Regular notification

Distribution date: 14 February 2020 | Final date for Comment: 20 April 2020

This draft resolution establishes the regulation with technical requirements for the market authorization, modifications and classification of sanitizing products, according to their potential risk to the health.

Products Covered: HS Code(s): 3402; 340119; 340120; 330290 (sanitizing products).

Regulation Type: Regular notification

Distribution date: 14 February 2020 | Final date for Comment: 14 April 2020

Sodium Formaldehyde sulfoxylate is a power full reducing agent. It also finds extensive applications in textile industry for printing and stripping dyed textiles prior to redying and discharge printing. It is  used in bleaching sugar cane juice for making jaggery, as a redoxs catalyst in emulsion of polymers and as a stabilizer/anti-oxidant in Pharmaceutical drug formulations. It also has a niche use as a water conditioner, reducing the amount of chlorine. The standard of the product stipulates minimum purity and maximum permissible content of heavy metals like lead, iron, copper and zinc etc. The locally manufactured or imported Sodium Formaldehyde Sulphoxylate shall conform to the Indian standard (IS 4505: 2015) 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: Sodium Formaldehyde Sulphoxylate (HS Code 2831 1020)

Regulation Type: Regular notification