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Mexico Proposes to Update Good Manufacturing Practices for Medical Device Facilities

Mexico’s Ministry of Health is seeking input by 13 August on a proposal to update the current good manufacturing practices for medical device manufacturing facilities (NOM-241-SSA1-2012). The definition of covered goods would change somewhat if the proposal is approved in its current form, and would include instruments, apparatus and machines (including the software necessary for their operation) as well implantable products or materials, diagnostic agents, materials, substances or similar products used alone or combined for (i) the diagnosis, prevention, surveillance or monitoring of, and/or assistance in, the treatment of diseases; (ii) the diagnosis, surveillance, monitoring, treatment, protection, absorption, drainage or assistance with the healing of an injury; (iii) the substitution or support of the anatomy of a physiological process; (iv) life support; (v) conception control; (vi) disinfection of medical devices; (vii) disinfectant substances; (viii) provision of information through a diagnostic in vitro examination of bodily samples; (ix) devices that incorporate animal and/or human tissues; and (x) in vitro fertilisation and assisted reproduction devices.

Medical devices would still be classified in one of three different categories:

  • Class I – medical devices known in medical practice whose safety and efficacy are proven and which are not generally introduced into the body;
  • Class II – medical devices known in medical practice that may have variations in their materials or their concentrations and which are generally introduced into the body for a period of less than 30 days; and
  • Class III – medical devices that are new or recently accepted in medical practice or that when introduced into the body remain there for more than 30 days.

NOM-241-SSA1-2018 would establish 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 storage and distribution warehouses. It would enter into force 180 days from the date of publication of a final regulation in Mexico’s official journal.

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