Tag Archive for: device manufacturers

Submission Changes in China: ToCs and the eRPS

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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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CHINA AMENDS MEDICAL DEVICE APPLICATION SUBMISSION PROCESS

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In an ongoing effort to refine and improve the systems and procedures for medical device registration in China, the National Medical Products Administration or NMPA (previously the CFDA) moved to a new on-line submission system and harmonized the applications table of contents to international standards.

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NEW OFFICE SPACE FOR ASIA ACTUAL PHILIPPINES

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Asia Actual is excited to announce the dedication of our new office space in the Philippines. The investment reflects the company’s commitment to the Philippines market and expectations for growth.

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INDIA TO REQUIRE REGISTRATION OF ALL CURRENTLY NON-NOTIFIED DEVICES

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Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate

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PHILIPPINES OFFICIALLY LAUNCHES NEW MEDICAL DEVICE REGULATIONS

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New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.

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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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