National Medical Products Administration (NMPA) is in charge of all pharmaceuticals and medical device regulations in China.
Medical devices are being classified into 3 classes. All according to their potential risks.
read more...Regulatory News
Japan, Changes to medical device regulations. What you need to know?
An official announcement was made in regards to the adoption of a new version of the Pharmaceuticals and Medical Devices (PMD) Act.
The latest version of the PMD Act covers issues
read more...Indonesia, Directorate of Assessment providing assurance for medical devices and healthy products.
Directorate of Assessment Indonesia is providing an assurance for medical devices and household health supplies distributed.
Before products enter the market for distribution all medical devices and household health supplies must
read more...UK, BREXIT it’s Official. What’s Next ?
UK, As the clock, strikes midnight on 31st January 2020.
The UK would have officially left the European Union and enter a transition period till 31st December 2020.
During this
read more...Indonesia, Exemption from Import Duties for Health Services Goods
The importation of health goods in Indonesia are normally subjected to a fiscal levy through customs duties and taxes in the framework of import (PDRI).
The importation of items are divided
read more...USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.
USA, Online Submissions of Orphan Designation Requests to be allowed by FDA.
Upcoming in the later part of 2020, we will see them move from a paper-based process to a new
read more...Looking at importing into The Philippines? What you need to take note?
Importing into the Philippines is pretty a straight forward process.
Provided the guidelines provided by the Bureau of Customs are adhered to.
Goods entering the Philippines’ territories are either regulated, restricted or
read more...Ministry of Health, Vietnam regulations on the management of medical equipment
Vietnam, Ministry of Health (Department of Medical Equipment and Construction) had a Business Dialogue Conference in regard to regulations on the management of medical equipment.
Here are some highlights on what
read more...Malaysia, Medical Devices advertising? Here’s what you need to know
As of Medical Device (Advertising) Regulations, no advertisement of any registered medical device can be done without the approval from the Ministry of Health Malaysia.
In order to make an advertisement
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