• 2020-05-06 09:09:41

There is a lack of order and strong regulations in the procurement of medical consumables. China’s government has therefore issued measures to stabilize the currently chaotic situation.

• 2020-05-06 09:07:05

In the recent years, CMDE has started to adjust the internal workflow to optimize the registration process. In 2015, they have changed the structure of the reviewing department. This time, they have set up two different departments for a faster operation.

• 2020-07-31 10:30:12

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 09:11:58

MOH established a Medical Device Risk Classification System on the MOH website called SIKLARA. This system aims to facilitate applicants in classifying medical devices and minimalize errors in class determination. However, this system is only available in Indonesian.

• 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.