Tag Archive for: import license

India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline

On October 1st 2023, the India CDSCO will enforce full license requirements for Class C and D non-notified medical devices as the final step of transitioning all medical devices under the new rules.

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)

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