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Trade and Industry Department The Government of the Hong Kong Special Administrative Region
Brand Hong Kong - Asia world city
MY COLOUR

Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 426/2

10 March 2022

Dear Sirs,

Commercial Information Circular No. 202/2022

Mexico : Updated Good Manufacturing Practices for Medical Device

The Mexican government has updated good manufacturing practices for medical device manufacturing facilities. The requirements as set out in NOM-241-SSA1-2021 will enter into force on 20 June 2023.

DETAILS

2. The covered goods would include instruments, apparatus, utensils, machines, software, implantable products, diagnostic agents, materials, substances or similar products used alone or in direct or indirect combination in humans for any of the following purposes:

  • the diagnosis, prevention, surveillance or monitoring of, and/or assistance in, the treatment of diseases;
  • the diagnosis, surveillance, monitoring, treatment, protection, absorption, drainage or assistance with the healing of an injury;
  • the substitution, modification or support of the anatomy of a physiological process;
  • life support;
  • birth control;
  • disinfection of medical devices;
  • disinfectant substances;
  • provision of information through a diagnostic in vitro examination of bodily samples;
  • devices that incorporate animal and/or human tissues; and
  • in vitro fertilisation and assisted reproduction devices.

3.The standard also sets out requirements regarding quality management systems, quality risk management, design and development, personnel, facilities and equipment, qualification and validation, production systems, quality control laboratories, release of finished products, stability studies, product recalls, outsourced activities, final destination of waste, and good practices for storage and distribution of the products concerned.

4.For details, traders are advised to consult their importers in Mexico and/or the relevant official notice (in Spanish) at http://dof.gob.mx/nota_detalle.php?codigo=5638793&fecha=20/12/2021.

ENQUIRIES

5.For enquiries concerning the content of this circular, please contact Miss K Y HO at telephone number 2398 5405.

Yours faithfully,

(Ken NG)
for Director-General of Trade and Industry

Note: While every effort is made to ensure the accuracy of the above information, the Department cannot guarantee this to be so and will not be held liable for any reliance placed on the same.