Tag Archive for: device manufacturers

HONG KONG ADVANCES TOWARDS MANDATORY MEDICAL DEVICE REGISTRATION

/in , /by

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.

Read more

INDIA OFFICIALLY REQUIRES REGISTRATION OF ALL NON-NOTIFIED DEVICES

/in , /by

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

Read more

4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIA

/in , , , , , , , , , , /by

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.

Read more

THAILAND NOTIFIES ALCOHOL-BASED STERILIZATION PRODUCTS

/in , /by

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

Read more

CHINA AMENDS MEDICAL DEVICE APPLICATION SUBMISSION PROCESS

/in , /by

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.

Read more

NEW OFFICE SPACE FOR ASIA ACTUAL PHILIPPINES

/in , /by

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.

Read more

INDIA TO REQUIRE REGISTRATION OF ALL CURRENTLY NON-NOTIFIED DEVICES

/in , /by

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

Read more