• 2020-02-12 15:56:38

The National Medical Product Administration (hereinafter referred to as NMPA) has released a list of medical device industry standards covering the new and amended standards from August 7th. Notable standards included in this exhaustive list, among others, include "Electrical safety standards for medical electrical equipment",

• 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 15:05:51

In July 2018, Medical Device Authority (MDA) had issued Circular Letter No.4 Year 2018. This was pertaining medical devices manufactured or imported into Malaysia for eventual exportation purposes only. According to Section 5(1) of Medical Devices Act 2012 (Act 737),

• 2020-02-12 15:04:32

In Medical Device Act 2012 (Act 737) of Malaysia, there is no specific provision for medical devices imported/exported from/to countries without diplomatic ties with Malaysia, such as Israel. Malaysia has not acknowledged Israel as an independent sovereign state.

• 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 15:01:28

In order to effectively inform the stakeholders of these new regulations, HSA Medical Branch published the updated documents containing the overview of the whole Singapore regulation unto their website.

• 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 14:58:58

In order to unify the management of medical device import license, MoH informed and stopped receiving the contents of request for adjustment of import license which has a validity period until Dec 31st, 2017 granted in accordance to Circular No. 30/2015/TT-BYT.