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Requirements on contact lenses import

03/10/2013 10:09:00
VGP –  Contact lenses belong to the list of products and goods that are likely unsafe for users and are punt under the management of the Ministry of Health (MoH) in accordance to Circular 44/2011/TT-BYT, dated December 6, 2011.

Question: I intend to import contact lenses to Viet Nam. What requirements do I need to satisfy?

Answer:

Under the Ministry of Health’s Circular 24/2011-TT-BYT, contact lenses are in the list of medical devices whose import is licensed by the MoH.

  1. Legal provision

Importers must have business registration certificate or investment certificate which sets out the scope of business of trading and importing medical devices.

  1. Human resource conditions

The officer who holds main responsibility for technical assistance shall meet one of the following requirements:

  • Having bachelor’s degree in Biomedical Electronics, Biomedical Physics; or University degree in Technology, Medicine, Pharmacy, as well as gaining the qualification on medical devices granted by legal medical technology training facilities or equivalent training certificates issued by foreign countries in accordance with equipment that the enterprise shall ask to import.
  • Having technicians and personnel capable of guiding the installation, warranty and maintenance of the medical devices related to those imported by the enterprise.
  1. Conditions of facilities
  • Having warehouses and other facilities to store medical devices, ensuring that the equipment shall be kept in proper conditions as to protect from the effects of light, temperature extremes, excessive humidity and other conditions.
  • Having fire and explosion prevention and fighting equipment and maintain a safe and hygienic environment in accordance with the provisions of law.
  1. Conditions of labeling of the imported medical device

Contact lenses (on this case) must be labeled in accordance with the Government’s Decree No. 89/2006/ND-CP, August 30, 2006 on labeling goods and Circular No. 09/2007/TT-BKHCN, April 6, 2007 of the Ministry of Science and Technology guiding the implementation of a number of articles of the Government’s Decree No. 89/2006/ND-CP, dated August 30, 2006 on labeling goods and several related regulations.

Hence, after establishing a company specializing in medical device imports and getting a business license, you are allowed to import contact licenses to Viet Nam./. 

PHAMVANTHUA
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