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PHILIPPINES OFFICIALLY LAUNCHES NEW MEDICAL DEVICE REGULATIONS

New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.

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)

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. 

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.

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

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.

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.

CLIENT SUCCESS: ICECURE MEDICAL GROWS SALES IN ASIAN MARKETS

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

MALAYSIA IMPLEMENTS ADVERSE EVENTS REPORTING REQUIREMENTS FOR MEDICAL DEVICES

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.

MEDICAL DEVICES SHIPMENTS DURING THE COVID-19 PANDEMIC

COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.