• 2020-07-31 10:23:22

National Committee on Prevention and Solution for AIDS concerned the important of individual infected situation. Encouragement of an action by increasing access Self-diagnosis of HIV infection which will be an essential key that will lead to the end of the AIDS problem.

• 2020-07-31 10:15:03

In order to effectively control Medical Device and in accordance with International Medical Device Control have agreed to classified Contact Lens Care Products as Notified Medical Device.

• 2020-05-06 09:41:29

The OMETA Seminar is back in 2019, to give those interested the tools to evolve and accelerate their business.

• 2020-05-06 09:31:48

PFDA starts to iron out flaws ahead of the upcoming implementation of AO 2018-0002. Things to keep an eye out for are the new guidelines for risk classification, separate scope for refurbished medical devices, guidelines and process of securing licenses for local medical products.

• 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.