Medical Use Products y Equipment

Medical Use Products y Equipment

Control Rules and Regulations of Medical use Products and Equipment was approved with Nº 825 on November 30th, 1998, letting therefore Archive 1 as:

“Those instruments, equipments, devices and other articles or elements, destined to human beings diseases diagnosis, prevention, treatment, replacement or anatomy modification which do not correspond to pharmaceutical products, medical food and cosmetic preparation who are referred on Sanitary Code articles 97, 98 and 99, could be only manufacture, import, trade or distributed in the country if they have applicable according to its nature.”

At the moment Products determined for Obligatory Certification are:

  • Preservatives: Rubber Latex Condoms NCh 2224/1
  • Latex Disposable Surgical Gloves NCh 2173
  • Medical Exam Latex Gloves NCh 2181
  • Disposable Sterile hypodermic needles NCh 2504/1 (ISO 7886/1)
  • Disposable Sterile hypodermic needles NCh 2503

Contacts

General Products:
Mr. Victor Díaz - vdiaz@cesmec.cl

General Products:
Ms. Loreto Araya - laraya@cesmec.cl