A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION

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Hong Kong’s Department of Health officially changed the name of the Medical Device Control Office (MDCO) to the Medical Device Division (MDD) at the end of 2019.

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INDIA OFFICIALLY REQUIRES REGISTRATION OF ALL NON-NOTIFIED DEVICES

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On February 11th, 2020 the Ministry of Health and Family Welfare published the Medical Device Rules, 2020 as an amendment to the Medical Device Rules

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INDONESIA CALLS FOR NEW ROUND OF E-CATALOGUE APPLICANTS

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In response to the overwhelming interest to a June invitation for registered medical device license holder to request inclusion of their device/s in the 2019 e-Catalogue enrollment, the Indonesia Ministry of Health (MOH) has extended the application deadline.

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INDIA COMPLIANCE MAINTENANCE: NOTIFIED BODY CHANGE

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Given recent conditions of Brexit, many companies are impacted with changes regarding their notified body. This change ultimately changes the CE Mark on labeling, thus requiring amendments to any existing Import Licenses in India.

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INDIA OFFICIALLY REQUIRES FIRST NEW DEVICES TO BE REGISTERED UNDER NEW MEDICAL DEVICE RULES, 2017

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