Tag Archive for: medical devices

HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION

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.

INDIA OFFICIALLY REQUIRES REGISTRATION OF ALL NON-NOTIFIED DEVICES

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

4 Product Development Decisions that Impact Sales Performance in Asia

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.

THAILAND NOTIFIES ALCOHOL-BASED STERILIZATION PRODUCTS

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

CHINA AMENDS MEDICAL DEVICE APPLICATION SUBMISSION PROCESS

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.

ASIA ACTUAL INTERVIEW: THE FUTURE OF MEDTECH IN ASEAN

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

NEW OFFICE SPACE FOR ASIA ACTUAL PHILIPPINES

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.