• 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.

• 2020-02-12 14:56:43

This month’s updates include the "Medical Devices Procurement for Healthcare Institutions ", “Announcement Regarding Registration Application of Medical Devices and Licensed Establishment”, “Exemption from Registration Requirement for Export Only Medical Device” among others. All information you need to know have been summed up in a nutshell.

• 2020-02-13 06:04:14

In connection with the stipulation of Government Regulation No. 24 of 2018 on Electronic Integrated Licensing Service or commonly named as OSS (Online Single Submission), the Ministry of Health of R.O.Indonesia stipulates Republic of Indonesia Ministry Regulation number 26 of 2018,

• 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.

• 2020-02-13 06:02:01

Medical Device Authority (MDA) is constantly trying to enhance the quality of service provided to all its customers. In line with this, MDA is currently conducting a customer satisfaction survey where all kinds of feedback are welcomed to help MDA constantly improve its output in the future.

• 2020-02-13 05:57:27

The Medical Device Authority (MDA) has been set on stricter implementing and enforcing the Medical Device Act 2012 (Act 737) via the gradual introduction of various policies. In 2016, it issued a policy providing a transition period of two (2) years for all local and foreign manufacturers importing,

• 2020-02-13 05:54:53

With an aim to strictly adhere to the provisions set by the ASEAN Agreement on Medical Device Directive (AMDD), the PFDA has issued a 3rd draft on the Rules and Regulations for the Registration Application for In-Vitro Diagnostic (IVD) Medical Devices to be placed in the Philippine Market.

• 2020-02-12 16:03:14

The National Telecommunications Commission of Philippines (NTC) regulates Radio Communication Equipment (RCE) and Customer Premises Equipment (CPE) under Section 1A of the Republic Act No. 3846 as amended. Specific regulations that cover for these devices are hereby summarized:

• 2020-02-12 16:01:31

HSA aims in improving the existing regulations related to product registration to benefit both product owners and locals. In June of 2018, HSA published new regulations on Telehealth products and Devices for Aesthetic purposes.

• 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.