• 2020-02-13 06:02:57

It has been earlier established that Medical Device Authority (MDA) and National Pharmaceutical Regulatory Agency (NPRA) of Malaysia will start to regulate drug-medical device and medical device-drug combination products together, starting July 1st, 2019.

• 2020-02-14 04:16:15

During the end of May, the CNDA redefined the management and classification of the intense pulsed light device (hereinafter referred to as "IPL devices") which is intended for hair removal. This kind of IPL device is now classified under Class II medical devices, with the amended classification code: 09- 03-04.

• 2020-02-14 04:14:45

Devices classification in Indonesia has followed ASEAN AMDD, which has been aligned to PERMENKES UU NO.62 years 2017. Medical Device classified into 4 risk classes (A,B,C,D based on level of risk)

• 2020-02-14 07:27:45

Thai FDA announces that they will modify the Medical Device Act and will be adopting the international risk classification method (Class I-IV) in order to comply with the ASEAN Agreement on Medical Device Directive.

• 2020-02-14 04:24:02

Thai FDA published an eye-related product classification checklist guide to help determine whether each product fall under the category of not medical device, medical device, drug, or cosmetic.

• 2020-02-14 07:50:05

The applicant may initiate the cancellation of the registration license of imported medical equipment to CFDA. This administrative application will not charge any application fee. The applicant shall prepare the submission documents to cancel the application. The CFDA will conduct a formal review on the cancellation application.

• 2020-02-14 14:48:09

This means that the Marketing Authorization License for Class B, C, and D medical devices will be delayed for one year from the original date set forth under Decree 36. Thus, with the official release of the Dispatch 7165 in Vietnam, some specific interim regulations are as follows:

• 2020-02-14 15:20:15

India's central medical device regulator, the Central Drugs Standards Control Organization (CDSCO) published, on November 1, 2017, a revised risk classification of medical devices and IVDs on the basis of their intended use. This is an extremely important development for the medical device and IVD industry because from January 1, 2018 onwards,

• 2020-02-15 06:32:14

On September 4th 2017, China Food and Drug Administration (CFDA) officially published the new revision of "Medical Device Classification Catalog". It will be implemented from August 1, 2018.

• 2020-02-15 09:11:48

Qualtech had successfully got second CFDA approval license of Class III implant product in the end of December, 2012.