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CHINA WARNS MANUFACTURERS ABOUT RISK ASSESSMENT REPORT DEADLINE

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.

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.

CHINA CHANGES CLINICAL DATA REQUIREMENTS FOR MEDICAL DEVICE REGISTRATION

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.

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.

DON’T PLAY ROULETTE WITH YOUR RUSSIAN TEST REPORTS

Considering the complexity of the importing test samples and the risk of test laboratories losing accreditation, it is important for manufacturers seeking medical or diagnostic device registration in Russia work with an experienced, local partner who can make an informed selection of test laboratories and take fast corrective action should the selected lab be affected.

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

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.

CHINA ENCOURAGES LOCAL MANUFACTURING OF FOREIGN MEDICAL DEVICES

China has been making efforts to encourage more direct investment. Along with the new Foreign Investment Law, the NMPA has also announced incentives for manufacturers opening facilities in China by making the application process easier and faster. 

THAILAND ELEVATES REGULATORY STATUS OF BREAST IMPLANTS

With Regulation B.E. 2562 (revision from regulation B.E. 2540), the Thai FDA increased the regulatory status of breast implants from Notified to Licensed (Class 4)