• 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.

• 2020-02-12 15:58:33

For the registration of any medical device with most regulatory authorities around the world, the first step would be to prepare the device’s technical documentation or a dossier. Technical documentation are the documented evidence, normally an output of the quality management system,

• 2020-02-12 15:58:33

For the registration of any medical device with most regulatory authorities around the world, the first step would be to prepare the device’s technical documentation or a dossier. Technical documentation are the documented evidence, normally an output of the quality management system,

• 2020-02-14 04:03:25

海外医機器技術協力会(OMETA), Japan Association of Medical Device Industry (JAMDI), DEKRA Japan, and Qualtech Japan are jointly organising an upcoming seminar in early July (July 6th, 2018) in Japan.

• 2020-02-14 04:02:32

Large medical equipment is a special type of equipment with complex technology, large capital investment and high operational cost, creating a great impact on medical expenses. This April, China government has issued “The New Acceptance Catalogue for Large Medical Equipment”.

• 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.