• 2020-02-14 04:19:20

In accordance with the requirements set forth in the "Standards management of medical equipment" and the "Management standard for revision of medical equipment standard system," the CNDA has initiated the FY 2018 - The Revision Plan of the Medical Device Standards last May 15.

• 2020-02-14 04:18:38

At the end of May, the China National Drug Administration (CNDA) has issued the "Technical Guidance for Electronic Submission of Medical Device Registration (Trial) (Draft) " (hereinafter referred to as the "Guidance") and sought for public opinion.

• 2020-02-14 04:17:45

During the early week in May, the Hainan Government has issued a further notice for “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. This is applicable to medical devices that are urgently needed for clinical purposes (hereinafter referred to as "emergency devices").

• 2020-02-14 04:17:02

In order to optimize the efficiency of approval process, China Drug Administration (CNDA) has proposed amendments for submission documents for the renewal and clinical trial application of medical devices. This notice was issued at the end of May.

• 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 04:15:34

MDCO will conduct a trial to study the feasibility for Local Responsible Persons (LRP) to demonstrate that their medical devices conforms with Hong Kong requirement by using marketing approvals obtained from the China Food and Drug Administration.

• 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 04:13:25

The regulatory standards for the approval of IVD devices keep on changing time to time because of the continuous improvements and modifications made related to their better performance level. There was a revision for “glucometer test strips” in 2013 as mentioned in IS/ISO 15197: 2013.

• 2020-02-14 04:09:43

MDA has released a new regulatory update, pertaining to Licensing Conditions for All Licensed Establishments under the Medical Device Authority in Malaysia. There have been some critical inclusions to the licensing requirements for all licensed establishments in MDA.

• 2020-02-14 04:08:31

Outcomes of these consultation sessions have been consolidated and new revisions to the existing guidance documents and issuance of new guidance documents are to be carried out in stages, after this.