• 2020-02-14 04:20:17

China National Drug Administration (CNDA) has revised the special approval procedures for innovative medical devices issued in 2014 to respond to current state. Drafts of the revision were released in early May and is currently open for public comments. This revision will be expected to take effect on October 1, 2018.

• 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 04:14:45

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 04:08:31

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.

• 2020-02-14 04:06:17

Vietnam Ministry of Health released the draft decree mention some points of Medical Device Management under Decree 36/2016/ND-CP. After the detailed analysis, Qualtech has outlined five major differences between the new and previous version of regulations:

• 2020-02-14 04:05:14

This month’s updates include the "Internet+Medical Health", “the Special Approval Procedure for Innovative Medical Devices”, “the Revision Plan of Medical Device Standards” among others. All information you need to know has been put in a nutshell:

• 2020-02-14 04:04:20

Administrative Order 2018-117, otherwise known as the “Effectivity of the New Schedule of Fees” was released in the 2nd of April, 2018 to inform all the FDA Stakeholders and the General Public that a new schedule of fees shall be implemented on the 30th of June 2018.

• 2020-02-12 16:02:17

Health Sciences Authority (HSA) published the list of new fees applicable to health products including Medical devices, on last August 1, 2018.