• 2020-05-06 08:30:49

Data still reflects rampant product recalls and occurrence of adverse events, indicating that products sold in the market are not safe as regulators think. This has prompted Health Agencies to develop a comprehensive PMS System.

• 2020-05-06 08:22:59

The NMPA has issued the first global regulatory on the lifetime of active medical devices. This guideline provides various aspects on lifetime evaluation, and all manufacturers producing active medical device should carefully regards this specific issue.

• 2020-05-06 07:56:13

The Act aims to specify Medical Device Control in accordance with the ASEAN Agreement on Provisions Medical instruments. As well as refresh the Act to suit the transformation of medical device industry, where all citizen can embrace standardized and qualified medical device.

• 2020-05-06 07:52:16

All locally marketed medical devices must have their post-market activities continuously monitored until their projected useful life expires. If the current AR or manufacturer go out-of-business, it is their responsibility to find replacement to take care of this or continue monitoring.

• 2020-05-06 07:48:03

The Indian Central Drugs Standard Control Organization (CDSCO) has set risk classifications for 12 products scheduled for notification and regulation as medical devices starting April 1, 2020.

• 2020-05-06 07:14:30

HSA warns the public risk of Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) on breast implants. HSA provided regulatory control currently in place to lower the risk of the device to existing and future patients in Singapore.

• 2020-05-06 07:09:04

The regulations of examination for testing institutions in China have been changing for the past 2 years. 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.

• 2020-05-06 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.