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Medical Device Authority (MDA), Ministry of Health (Revised Announcement)

Dear Valued Distributors,

Recently, Enagic (Malaysia) Sdn Bhd has had a discussion with the Medical Device Authority (MDA) and Food Safety and Quality Division (FSQ), Ministry of Health in regards to the Enagic machines, its properties and status as a ‘medical device‘ and miraculous and therapeutic claims made by distributors.

Medical Device Authority has concluded that Enagic machines are not a medical device and has instructed us to remove the following effectively immediately:

  • “Medical Device” and “Endorsed by the Japanese Association of Preventative Medicine for Adult Disease” statements in any of Enagic (Malaysia) publications; electronic and hardcopy;
  • Certificate by ‘Japanese Association of Preventative Medicine for Adult Disease’;and
  • Certificates by Ministry of Health, Labour and Welfare Government of Japan; ‘License Number: 27B2X00070’ and ‘License Number: 27BZ006010’.

Distributors are prohibited to promote the sale by publishing any advertisement relating or likely to cause any person to believe that Enagic machines are considered as ‘medical device’ and none of the distributors  may say, directly or indirectly; discuss or suggest that any diagnosis, evaluation prognosis, description, treatment, therapy or management or remedy of illness, ailment or disease can be improved by consumption, use or application of the water produced and/or product by producing the certificates as mentioned above towards the public in any means necessary.

On the other hand, Enagic (Malaysia) Sdn Bhd has updated the information under ‘Regulations’ section which includes below:

  • Trade Mark Act 1976
  • Medicine (Advertisement & Sale) Act 1956
  • Food Act 1983
  • Medical Device Act 2012
  • Enagic Policies & Procedures
  • Personal Data Protection Act 2010

To have access to the full articles, you may click http://www.enagic-my.com/compliance/regulation/

If you have any queries on the above, kindly call our Compliance Executive Officer at 03-2282 2332.

Your kind understanding and continued support of Enagic is greatly appreciated.

Thank you
Enagic Malaysia Sdn Bhd

 

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