Regulatory Updates

Distribution date: 07 January 2022

This Normative Instruction approves the list of Technical Standards for the certification of conformity of devices under the Sanitary Surveillance regime.

Products Covered: HS (3006)

Regulation Type: Regular notification

Distribution date: 07 January 2022

This resolution contains provisions on the identification of regularized medical devices at Anvisa, through the Unique Device Identification (UDI) system.

Products Covered: HS (3006)

Regulation Type: Regular notification

Distribution date: 07 January 2022 | Final date for Comment: 08 March 2022

The Food and Drug Administration (FDA) proposes to revise the list of ingredients prohibited in cosmetic products. Details of the regulated scope are specified in the attached documents.

Products Covered: Cosmetics

Regulation Type: Regular notification

Distribution date: 07 January 2022 | Final date for Comment: 08 March 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Cadusafos

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.03, 08.05, 08.07, 08.10, 08.11 and 08.14) - Spices (HS Code: 09.10) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, and 12.12)

Regulation Type: Regular notification

Distribution date: 07 January 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemical Pesticide: Broflanilide

Products Covered: - Natural honey (HS Code: 04.09) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.03, 07.04, 07.05, 07.06, 07.08, 07.09, 07.10 and 07.14) - Spices (HS Code: 09.10)

Regulation Type: Regular notification

Distribution date: 06 January 2022 | Final date for Comment: 03 February 2022

To amend the provisions for the pyrogen test, to delete the test for leukopenic toxicity, and to introduce the endotoxin test instead of the test for toxicity to mouse weight gain in the section for “Influenza HA Vaccine”.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 06 January 2022 | Final date for Comment: 09 January 2022

All wastepaper and metal scrap intended to be imported into Malaysia are subject to inspection process and issuance of Certificate of Approval  as per the Customs (Prohibition of Imports) (Amendment) (No.X) Order 2021. The requirements on all incoming importation of wastepaper and metal scrap into Malaysia are specified in the Guidelines for Importation and Inspection of Waste Paper and the Guidelines for Importation and Inspection of Metal Scrap. The two guidelines have been published on SIRIM QAS website for comments from 27 February 2021 until 15 March 2021. Various engagements with local and international stakeholders have been conducted from February 2021 until November 2021. Interim measure have been enforced pending the implementation of the Guidelines for Importation and Inspection of Metal Scrap.  

Products Covered: i. Recovered (waste and scrap) paper and paperboard: HS Code 4707.10: Unbleached kraft paper or paperboard or corrugated paper or paperboard HS Code 4707.20: Other paper or paperboard made mainly of bleached chemical pulp, not coloured in the mass HS Code 4707.30: Paper or paperboard made mainly of mechanical pulp (for example, newspapers, journals and similar printed matter) ii. Waste and scrap metal: HS Code 7204: Ferrous waste and scrap; re-melting scrap ingots of iron or steel HS Code 7404: Copper waste and scrap HS Code 7602: Aluminium waste or scrap

Regulation Type: Regular notification

Distribution date: 05 January 2022 | Final date for Comment: 07 March 2022

The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to remove the prescription status for veterinary use by removing this ingredient from the Veterinary Prescription Drug List (PDL). 

Products Covered: Prescription status of medicinal ingredients for veterinary use in feed (ICS: 11.220; HS 3004.50.55)

Regulation Type: Regular notification

Distribution date: 05 January 2022 | Final date for Comment: 06 March 2022

The notified draft text amends Annexes 2 and 3 and Article 8 and incorporates Annex 4 into the current Regulations approved pursuant to Supreme Decree No. 001-2004-EM.

Products Covered: National subheading description: 2612.10.00.00 Uranium ores and concentrates; 2612.20.00.00 Thorium ores and concentrates; 2844.10.00.00 Natural uranium and its compounds; alloys, dispersions (including cermets), ceramic products and mixtures containing natural uranium or natural uranium compounds; 2844.20.00.00 Uranium enriched in U 235 and its compounds; plutonium and its compounds; alloys, dispersions (including cermets), ceramic products and mixtures containing uranium enriched in U 235, plutonium or compounds of these products; 2844.30.00.00 Uranium depleted in U 235 and its compounds; thorium and its compounds; alloys, dispersions (including cermets), ceramic products and mixtures containing uranium depleted in U 235, thorium or compounds of these products; 2844.40.10.00 Radioactive residues; 2844.40.90.00 Radioimmunoassay (RIA) kits and radioactive sources; 2844.50.00.00 Spent (irradiated) fuel elements (cartridges) of nuclear reactors; 2845.10.00.00 Heavy water (deuterium oxide); 8401.10.00.00 Nuclear reactors; 8401.20.00.00 Machinery and apparatus for isotopic separation, and parts thereof; 8401.30.00.00 Fuel elements (cartridges), non-irradiated; 8401.40.00.00 Parts of nuclear reactors; 8535.40.10.00 Only: Ionizing lightning arrestors (radioactive); 8543.10.00.00 Particle accelerators (cyclotron, synchrotron); 9022.12.00.00 Computed tomography apparatus; 9022.13.00.00 Other, for dental uses; 9022.14.00.00 Only: Bone densitometers, mammography devices and other medical, surgical or veterinary equipment; 9022.19.00.00 Only: Apparatus for monitoring, diffraction or analysis containing radioactive material; 9022.21.00.00 Only: Caesium-137 teletherapy units for medical use; 9022.21.00.00 Only: Apparatus for medical, surgical, dental or veterinary use; 9022.29.00.00 Only: Linear accelerators and teletherapy units, nuclear gauges (densitometers; level, weight, moisture, fill, thickness, grammage gauges, etc.), high dose rate (HDR) or low dose rate (LDR) equipment containing radioactive material; 9022.30.00.00 X-ray tubes; 9025.80.30.00 Only: Densitometers containing radioactive material; 9026.10.12.00 Only: Level gauges containing radioactive material; 9026.10.19.00 Only: Others containing radioactive material

Regulation Type: Regular notification

Distribution date: 05 January 2022 | Final date for Comment: 06 March 2022

This Draft East African Standard specifies requirements, sampling and test methods for crepe bandages.

Products Covered: Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (excl. adhesive dressings and other articles having an adhesive layer) (HS code(s): 300590); Textile fabrics (ICS code(s): 59.080.30)

Regulation Type: Regular notification