• 2020-02-12 15:54:36

In carrying out the medical device registration process in Indonesia the applicant must fulfill administrative and technical documents requirements. Indonesia MOH had a seminar to describe how to prepare the submission document. Qualtech summarizes as this article.

• 2020-02-12 15:09:17

Nearly eight months after the implementation of the Medical Device Rules 2017, the Indian Pharmacopoeia Commission (IPC) has brought out the first reference document for medical devices manufactured and sold in the country.

• 2020-02-12 15:06:56

MDA has issued a new announcement regarding registration application of medical devices and licensed establishment under Medical Devices Act 2012 (Act 737) which are still pending, following the end of transition period.

• 2020-02-12 15:03:41

In Malaysia, medical devices procurement by local healthcare institutions are heavily controlled in order to make sure the supplied medical devices are safe and efficient. For starters, there are many procurement methods, depending on the product’s market value.

• 2020-02-12 15:00:06

Slight revision on guidance documents about Singapore Standards and Medical devices for exhibition were added last July 2018.

• 2020-02-12 16:00:39

The list of medical equipment defined with HS codes issued together with this Circular is the basis for organizations and individuals to make customs declarations when exporting or importing medical equipment into Vietnam.

• 2020-02-14 04:01:45

The Hainan Government has issued “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”, which shall be applicable for the importation and approval of medical equipment urgently needed in the clinical setting.

• 2020-02-14 04:00:29

In order to enhance the requirements for clinical trial approval for non-active implantable medical devices, CNDA has issued “the Guidelines for the Submission Documents of Clinical Trial Application for Non-active Implantable Medical Devices” (hereinafter referred to as the Guideline) in June.

• 2020-02-14 03:59:43

In early June, CNDA had issued a draft consisting of the fourth batch of medical device catalogues to be exempted from clinical trials along with the revisions of the first three batches of catalogues, in able to catch up with the upcoming classification to be implemented in July. In this regard, CNDA is currently accepting comments from the public until the end of June 2018.

• 2020-02-14 03:58:45

In order to optimize the evaluation system of medical device and encourage the innovation of medical equipment, the Ministry of Justice of China has drafted some changes on Regulation on the Supervision and Administration of Medical Devices. This draft is open for public comments until July 24.