Tag Archive for: new requirements

ASIA ACTUAL INTERVIEW: THE FUTURE OF MEDTECH IN ASEAN

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Learn about the significant opportunities and challenges medical device companies can expect when accessing this dynamic and thriving market.

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CHINA ENCOURAGES LOCAL MANUFACTURING OF FOREIGN MEDICAL DEVICES

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China has been making efforts to encourage more direct investment. Along with the new Foreign Investment Law, the NMPA has also announced incentives for manufacturers opening facilities in China by making the application process easier and faster. 

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THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS

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With Regulation B.E. 2562 (revision from regulation B.E. 2540), the Thai FDA increased the regulatory status of breast implants from Notified to Licensed (Class 4)

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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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eRPS System: China National Medical Product Administration’s (NMPA) medical device registration system

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Manufacturers interested in registering a medical device in China can now submit electronic documents online through the new eRPS system.

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Philippines Proposes New Fees for Medical Device Registration

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The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D. 

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