IMPLEMENTATION LEVEL

National

AFFECTED FLOW

Inflow

ANNOUNCED AS TEMPORARY

No

NON-TRADE-RELATED RATIONALE

No

ELIGIBLE FIRMS

all

JUMBO

No

TARIFF PEAK

No
← back to the state act
Inception date: 25 Oct 2010 | Removal date: open ended

Import-related non-tariff measure, nes

On October 25, 2010, the Ministry of Health of Mexico published in the Diario Oficial an agreement that recognizes certain requirements established under U.S. and Canadian health regulation as equivalent to those provided for in Mexican laws.
In accordance with Mexican Law, medicines and other health products are required to obtain from the health authorities an authorization called sanitary register ('registro sanitario') prior to their marketing.
The publication establishes that as of November 25, 2010, the Mexican health authorities recognize that:
n The requirements established under certain sections of the U.S. Federal Food, Drug and Cosmetic Act, the Code of Federal Regulations, as well as certain tests an inspections of the Food and Drug Administration are equivalent to the requirements established under the Mexican laws to allow for the marketing of medical equipment.
n The requirements established under certain sections of the Canadian Food and Drugs Act and Medical Devoices Regulations are equivalent to the requirements established under the Mexican laws to allow for the marketing of medical equipment.

AFFECTED COUNTRIES

MAP
TABLE
EXPORT

AFFECTED SECTORS AND PRODUCTS

352 Pharmaceutical products
3005 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.
300510 Adhesive dressings and other articles having an adhesive layer
300590 Other
354 Chemical products n.e.c.
3822 Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, other than those of heading 30.02 or 30.06; certified reference materials.
382200 Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, other than those of heading 30.02 or 30.06; certified reference materials.
481 Medical & surgical equipment & orthopaedic appliances
9018 Instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electromedical apparatus and sighttesting instruments.
901811 Electrocardiographs
901812 Ultrasonic scanning apparatus
901813 Magnetic resonance imaging apparatus
901814 Scintigraphic apparatus
901819 Other
901831 Syringes, with or without needles
901832 Tubular metal needles and needles for sutures
901839 Other
901849 Other
901850 Other ophthalmic instruments and appliances
901890 Other instruments and appliances
9019 Mechanotherapy appliances; massage apparatus; psychological aptitudetesting apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus.
901910 Mechanotherapy appliances; massage apparatus; psychological aptitudetesting apparatus
901920 Ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus
9021 Orthopaedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect
902110 Orthopaedic or fracture appliances
902121 Artificial teeth
902129 Other
902131 Artificial joints
902139 Other
902140 Hearing aids, excluding parts and accessories
902150 Pacemakers for stimulating heart muscles, excluding parts and accessories
902190 Other
9022 Apparatus based on the use of Xrays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus, Xray tubes and other Xray generators, high tension generators,
902212 Computed tomography apparatus
902214 Other, for medical, surgical or veterinary uses
902219 For other uses
902229 For other uses
902230 Xray tubes
902290 Other, including parts and accessories

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