• 2020-05-06 07:05:38

The Medical Device Market of the Philippines offers Foreign Manufacturers a wealth of opportunities, due to the strong demand for innovative devices and the market’s extreme dependency on foreign imports. With local production covering less than 10% of the national demand and being restricted to a small variety of products, the Philippines promise favorable conditions for foreign companies interested in expanding to Asia.

• 2020-05-06 06:48:58

To enhance the efficiency of the registration process, NMPA sets up an online submission system. Local China agents of imported medical devices shall apply for an account within the system via Certificate Authority (CA) certificate. Further details are to be found below in this article.

• 2020-05-06 06:48:33

Currently the State Administration for Market Regulation (SAMR) plans to re-organize the structure of testing centers, from solely permitting official institutions to now also opening up the procedure to public 3rd-party testing organizations.

• 2020-07-31 10:40:17

ThaiFDA is highly concerned with the health and the well-being of the people abrupt from the situation of PM.2.5 in Thailand. Respectively, the “Letter of Notification: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance” was announced.

• 2020-05-06 06:04:19

Thai FDA is highly concerned with the health and the well-being of the people abrupt from the situation of PM.2.5 in Thailand. Respectively, the “Letter of Notification: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance” was announced.

• 2020-05-06 05:54:02

Qualtech is extending its service range and adds yet another country to its service list. Full assistance regarding Thailand medical device registration, local representation, and importation is now offered to our current and potential clients.

• 2020-05-06 05:18:20

The draft guidance on labeling is catered to provide a comprehensive information on medical device and IVD use among patients and/or end-users. The Guidance is expected to take effect after 15 days following its official publication.

• 2020-05-06 05:10:35

In a recently issued revised guideline on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737), MDA specified that it can drop an ongoing application from MeDC@St system if it exceeds a 90 days stop-clock-time and any new applications which do not conform to requirements specified will be rejected, non-refundable.

• 2020-05-06 05:08:37

MDA has reminded all stakeholders that it is unlawful to market unregistered medical devices with no clinical evidence in Malaysia. In a latest announcement, MDA advises the general public not to believe and be affected by advertisements which contain claims made on this type of devices.

• 2020-05-06 03:45:58

MDA has issued a new guidance document on notification of medical device for special access. A draft for this guidance document was issued earlier this year and based on public comments and suggestion, some changes have been made in the official release document.