Tag Archive for: medical device sales

Asia Actual is the Best Medical Device Consulting Company in Asia

Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”

LAUNCHING AI DEVICES AND SOFTWARE AS MEDICAL DEVICES IN THAILAND

The novel characteristics of AI software and Software as Medical Devices (SaMDs) are stressing bureaucratic regulatory, customs and taxation systems around the world. Thailand is no exception.

CHINA: REGULATORY AND COMMERCIAL UPDATES

The NMPA has been highly active in 2020 updating many of their regulations, standards and processes. If you’re considering entering the Chinese market, please contact us to identify how some of the new changes could affect your time and costs. Asia Actual Can Help Navigate the Evolving Regulatory Process in China

THAILAND: TIPS FOR IMPORTING MEDICAL DEVICES IN A COMPLEX MARKET

Importing medical devices into Thailand is more difficult than in other countries in the region. It is important to work with an importer with staff experienced with medical device imports to avoid customs clearance delays and added costs.

CHINA MEDICAL DEVICE AND IVD CLINICAL TRIAL EXEMPTION LIST

As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.

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.

Submission Changes in China: ToCs and the eRPS

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

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.

CHINA TAKES STEPS TO ENSURE QUALITY OF COVID-19 RELATED EXPORTS

Chinese officials are taking steps to reduce fraudulent exports. Only products with NMPA registration can be exported to ensure standards and quality during COVID-19 crisis.

CLIENT SUCCESS: ICECURE MEDICAL GROWS SALES IN ASIAN MARKETS

Asia Actual assists IceCure in achieving goals for continued expansion in Asia