Tag Archive for: medical device sales

Asia Actual is the Best Medical Device Consulting Company in Asia

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

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.”

Read more

CHINA MEDICAL DEVICE AND IVD CLINICAL TRIAL EXEMPTION LIST

/in , /by

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.

Read more

LAUNCHING AI DEVICES AND SOFTWARE AS MEDICAL DEVICES IN THAILAND

/in , /by

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.

Read more

CHINA: REGULATORY AND COMMERCIAL UPDATES

/in , /by

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

Read more

THAILAND: TIPS FOR IMPORTING MEDICAL DEVICES IN A COMPLEX MARKET

/in , /by

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.

Read more

CHINA CHANGES CLINICAL DATA REQUIREMENTS FOR MEDICAL DEVICE REGISTRATION

/in , /by

The changes to clinical data requirements will significantly decrease the regulatory burden for many medical device manufacturers seeking to access the Chinese market by eliminating the time and expense of conducting a local clinical trial.

Read more

TROUBLESHOOTING U.S. HOSPITAL SALES RESULTS

/in , , /by

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

Read more

CHINA WARNS MANUFACTURERS ABOUT RISK ASSESSMENT REPORT DEADLINE

/in , /by

Asia Actual works with highly experienced professionals in China that can provide you with accurate and timely Risk Assessment reports for your products that will not only satisfy the NMPA’s requirements but could also be used for updating Clinical Evaluation Reports in other markets.

Read more

HONG KONG EXTENDS PILOT PROGRAM TO RECOGNIZE CHINA AND KOREA AS REFERENCE COUNTRIES

/in , /by

By allowing manufacturers to show conformity to the MDD’s assessment requirements by using NMPA or MFDS approvals, Chinese and Korean manufacturers would save 6-9 months during the application process.

Read more

MALAYSIA IMPLEMENTS ADVERSE EVENTS REPORTING REQUIREMENTS FOR MEDICAL DEVICES

/in , /by

On July 1st, 2020 the Malaysia Medical Device Authority (MDA) will implement the Medical Device (Duties and Obligations of Establishment) Regulations 2019, implementing guidelines for Adverse Event (AE) Reporting within the current mandatory registration system.

Read more