2013 Successful ARPA & TFDA Training in Taipei
- 2020-02-15 09:00:48
The successful forum had been held on April 15th, 2013 at Taipei.
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CFDA approval of Class III implant by Qualtech
- 2020-02-15 09:11:48
Qualtech had successfully got second CFDA approval license of Class III implant product in the end of December, 2012.
More SINGAPORE: Cybersecurity Labelling Scheme for Medical Devices ( CLS(MD) Sandbox: Latest Updates and Calls for Medical Device Manufacturers
- 2024-06-19 09:35:10
The rise of connected medical devices has revolutionized healthcare, but it has also introduced new cybersecurity challenges. To address these concerns, Singapore has implemented the CLS(MD) scheme, a collaborative effort to enhance medical device cybersecurity.
This article explores the latest updates on the CLS(MD) Sandbox program, its background, key details, and how medical device manufacturers can benefit from participation.
Evaluation Principles of Medical Devices for Home Medical Care in Japan
- 2021-10-27 07:43:08
Every once in a while, Japanese Ministry of Health, Labor and Welfare (MHLW) issues notices to announce evaluation principles of “Next-Generation Medical Devices,” to accelerate review and approval process of new medical devices which has high demands and high feasibility of product realization. Since 2008, there have been 27 issuances by MHLW listed in the end of this article.
In this article, we will introduce list of “Next-Generation Medical Devices” that were announced in the past notices as well as were one of the notices issued in September of 2020, “Evaluation Index of Medical Devices for Home Medical Care”.
Evaluation Principles of Medical Devices for Home Medical Care in Japan
- 2021-10-27 07:34:31
Every once in a while, Japanese Ministry of Health, Labor and Welfare (MHLW) issues notices to announce evaluation principles of “Next-Generation Medical Devices,” to accelerate review and approval process of new medical devices which has high demands and high feasibility of product realization. Since 2008, there have been 27 issuances by MHLW listed in the end of this article.
In this article, we will introduce list of “Next-Generation Medical Devices” that were announced in the past notices as well as were one of the notices issued in September of 2020, “Evaluation Index of Medical Devices for Home Medical Care”.
THAILAND: Ministry of Public Health Announces Medical Device Definitions that Manufacturer and Importer Must Proceed Medical Device to be Notified Registration – September, 2020
- 2020-09-15 06:58:50
Thailand’s Ministry of Public Health has announced a set of medical device definition for manufacturers and importers to follow when registering their medical device according to risk-based classification, to gradually endorse the transition of Thailand away from policy-based classification.
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