• 2020-02-14 07:37:59

CFDA has released the draft of 3D-printed medical device guidance during the last week of February. The draft guidance provides the general requirements of registration rules on 3D printed medical device.

• 2020-02-14 07:36:53

The state council of China issued a cabinet report during the congressional sessions in March. China government plans to reform many agencies and establish a new administration, market supervision administration. The affected agencies include the State Administration of Industry & Commerce,

• 2020-02-14 07:35:54

International Medical Device Regulators Forum (IMDRF) held a meeting in China during March 20 to 22. The current chairman, China FDA, proposed two projects and get the support from all IMDRF members.

• 2020-02-14 07:34:46

Medical device regulations in China have changed frequently in the recent years, such as updating of multiple national standard andindustry standards, issuing of product guidance and administrative directives. With its 10-year experience in China's active medical device registration,

• 2019-11-15 03:00:54

The Government of India and the Ministry of Health and Welfare have issued guidelines for the grouping of medical devices on the wish to apply for a license to import or manufacture medical devices for sale and distribution in India.

• 2019-11-15 02:57:23

The Ministry of Industrial Policy and Promotion, the Ministry of Commerce and Industry, and the Indian government have recently issued Public Purchase Order No. 17 in order to force procurement entities to use local suppliers as the priority procurement preference for medical equipment, as well as other products and services related to the pharmaceutical sector. (PPO) guidelines.

• 2020-02-14 07:51:46

The regulatory body for medical devices is Division of Medical Devices and Cosmetics under Taiwan Food and Drug Administration (TFDA). The important legal rules that govern Medical Device Affairs are the Pharmaceutical Affairs Act and the Regulations for Governing the Management of Medical Device.

• 2020-02-14 07:50:54

The Unique Device Identification (UDI) system is a set of alphanumeric codes that serves to enhance monitoring activities for medical devices. It consists two parts: (1) UDI (an array of alphanumeric codes) and (2) UDI carrier which come in three distinct types: (a) QR code, (b) Bar code, or (c) RFID/NFC.

• 2020-02-14 07:50:05

The applicant may initiate the cancellation of the registration license of imported medical equipment to CFDA. This administrative application will not charge any application fee. The applicant shall prepare the submission documents to cancel the application. The CFDA will conduct a formal review on the cancellation application.

• 2020-02-14 07:49:21

This major announcement was made by the Department’s Halal Hub Division director, Datuk Sirajuddin Suhaimee in early February 2018, who said the certification, drafted together with the Department of Standards Malaysia, was now at the final stage of public feedback.