Tag Archive for: device manufacturers

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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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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4 Product Development Decisions that Impact Sales Performance in Asia

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US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.

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THAILAND NOTIFIES ALCOHOL-BASED STERILIZATION PRODUCTS

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The Thai FDA increased the regulatory status of alcohol-based sterilization devices from General to Class 2 Notified.

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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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