Premier Li signs regulation on medical device supervision
7 years, 10 months ago

Premier Li signs regulation on medical device supervision

China Daily  

Updated : 2017-05-22 Premier Li Keqiang has signed a revised regulation on the management and supervision of medical devices in order to standardize the use of large medical equipment and ensure safety. According to the regulation, the list of large medical devices will be approved by the State Council and health authorities will supervise and evaluate the use of these devices. Medical institutions should obtain approval from health authorities at the provincial level and above before installing large medical equipment, it said. Institutions that install large medical equipment should have the required technical conditions, the ability to use the devices, ancillary facilities and qualified technicians.

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Centre to reclassify medical devices to bring regulatory uniformity
2 months, 2 weeks ago

Centre to reclassify medical devices to bring regulatory uniformity

Live Mint  

New Delhi: In an attempt to bring regulatory uniformity in medical devices, the government plans to classify around 1,178 medical devices into four categories based on their risk approach under the Medical Device Rule, 2017. As part of the plan, the Central Drugs Standards Control Organization is revising the existing list of medical devices and classifying them into four categories—interventional …

China deepens comprehensive reform to strengthen drug, medical device regulation
2 months, 3 weeks ago

China deepens comprehensive reform to strengthen drug, medical device regulation

China Daily  

BEIJING -- China has issued a guideline on comprehensively deepening the reform of regulation of drugs and medical devices to promote the high-quality development of the pharmaceutical industry. The guideline stipulates that by 2027, the legal and regulatory frameworks for drug and medical device supervision will be more enhanced, while the quality and efficiency of review and approval processes for …

Improved regulations to facilitate medicine, equipment imports to Guangdong
7 months, 3 weeks ago

Improved regulations to facilitate medicine, equipment imports to Guangdong

China Daily  

A statement from the Guangdong Provincial People's Congress on Wednesday detailed new regulations aimed at making it easier to import medicine and medical equipment from Hong Kong and Macao to cities in Guangdong. The rules also promote adding crucial medicines and equipment from Hong Kong and Macao to general health insurance plans and endorse using personal accounts from basic medical …

China Medical Device Standards Management Annual Report (2023)
10 months, 2 weeks ago

China Medical Device Standards Management Annual Report (2023)

China Daily  

Data overview of medical device standards Release data on formulation and revision plan of medical device standards 1. In 2023, the Standardization Administration approved and issued 52 national standard projects for medical devices, which were divided into formulation projects and revision projects according to the formulation and revision of standards; they were divided into mandatory standard projects, recommended standard projects, …

Govt taps hospitals on medical devices
1 year, 8 months ago

Govt taps hospitals on medical devices

Live Mint  

New Delhi: The Central government is considering a proposal on whether the bigger hospitals like AII India Institute of Medical Sciences, Post Graduate Institute of Medical, Education & Research Chandigarh, Medanta and Directorate General of Armed Forces Medical Services Armed Forces Hospitals should be allowed to procure or import medical devices directly from the manufacturers. Currently, some of the hospitals …

Provisions for Supervision and Administration of Medical Device Manufacturing
2 years, 5 months ago

Provisions for Supervision and Administration of Medical Device Manufacturing

China Daily  

Provisions for Supervision and Administration of Medical Device Manufacturing Chapter I General Provisions Article 1 These Provisions are formulated in accordance with the Regulations on Supervision and Administration of Medical Devices for the purpose of strengthening supervision and administration of medical device manufacturing, regulating the manufacturing activities of medical devices, and ensuring the safety and effectiveness of medical devices. To …

Province simplifies medical imports
3 years, 6 months ago

Province simplifies medical imports

China Daily  

Updated: 2021-08-31 By LI WENFANG in Guangzhou China Daily Guangdong provincial authorities have qualified five hospitals for importing urgently needed pharmaceuticals and medical devices used in Hong Kong and Macao. The moves are the latest steps in implementing a program from eight ministries and commissions in November aimed at the innovative supervision of pharmaceuticals and medical devices in the Guangdong-Hong …

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