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Philippines Proposes New Fees for Medical Device Registration

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. 

Voluntary Medical Device Registration in Hong Kong

Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.

ARTIFICIAL INTELLIGENCE (AI) SOFTWARE REGISTRATION IN SINGAPORE

In December 2019, the Health Sciences Authority (HSA) of Singapore’s Ministry of Health released guidelines regarding software registration in Singapore, including a major section dedicated to AI software.

U.S. Medical Device Industry – Open for Business

Uncertainty.  If there is one word that best describes the global outlook during the 2020 pandemic this might be one that everyone can agree on. 

VIETNAM: HIGH GROWTH FAST MARKET ACCESS

Vietnam has been quietly transforming their economy of 100 million people into a regional powerhouse. Through a combination of significant private investment, the US-China trade war, and their highly successful handling of the Coronavirus, Vietnam’s economy is expected to rebound quickly, especially with regards to manufacturing.

TROUBLESHOOTING U.S. HOSPITAL SALES RESULTS

Medical device manufacturers looking to establish or improve sales in the US market should contact our team for market insight and strategy development.

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

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

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.