MEDICAL DEVICE

Guangdong Updates Epidemic Control Guideline for Imports by Medical Device Companies

28 July 2022

Recently issued by the Guangdong Provincial Medical Products Administration, a new set of epidemic prevention and control guidelines for the import of goods by medical device companies specifies how medical device enterprises are to receive, unpack, disinfect, store and dispose of packaging materials, and how to utilise in production the raw materials, dental moulds and other items imported during the period of epidemic prevention and control. More

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GBA Supports Marketing of Drugs and Registration of Medical Devices from Hong Kong and Macao

21 July 2022

The National Medical Products Administration recently unveiled plans to support Hong Kong and Macao-registered operators to produce drugs and medical devices in the Greater Bay Area (GBA). The aim is to promote the integration of the GBA’s biomedicine sector, and to spur collaborative development in the GBA’s medical and pharmaceutical sectors. More

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Guangdong Issues GBA Guidance for Import of Hong Kong-Registered Medicines

14 July 2022

According to guidance issued by Guangdong, steps have been taken to facilitate the import of Hong Kong and Macao-registered medicines and medical devices for urgent clinical use by mainland healthcare institutions and patients in the Greater Bay Area (GBA). More

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China Revises Medical Devices Classification Catalogue

28 April 2022

As of 28 March, applications for registration of devices under the “non-ablative radio frequency therapy equipment” category are being accepted by the National Medical Products Administration. This follows China’s recent update of the Medical Devices Classification Catalogue, which affects 27 types of medical devices. More

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New Measures for Production and Operation of Medical Devices Take Effect in May

21 April 2022

Newly revised measures released by the State Administration for Market Regulation for the supervision and administration of medical device production and operation will take effect on 1 May. A system of registration and record-filing in relation to medical devices will help to optimise administrative licensing procedures and supervision. More

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Guangdong Announces Progress in Monitoring Medical Device Adverse Events

18 March 2022

In its notice on the work of medical device adverse event monitoring in 2022, the Medical Products Administration of Guangdong said registration and record-filing parties must carry out adverse event monitoring and implement quality management systems in medical device production. More

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China Starts Sample Inspections of Medical Devices for Quality

17 March 2022

The National Medical Products Administration recently started sample inspections of medical devices for quality. The departments responsible for this year’s re-inspections are provincial-level medical products administrations in those places where the registration and record-filing parties or import agents pertaining to the devices are located. The authorities only need to process applications for re-inspections once. Re-inspection agencies may not refuse these duties once selected. More

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Validity of Import Authorisation for Urgently Needed Drugs and Medical Devices Starts in March

25 February 2022

As announced by the Guangdong provincial government and the General Administration of Customs, authorisation letters for imports of drugs and medical devices for urgent clinical use will be valid as of 1 March. Original authorisation letters can still be used within their validity period with no need for renewal but will become invalid upon expiration. More

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China Adopts New Emergency Approval Procedures for Domestic and Imported Medical Devices

31 January 2022

The National Medical Products Administration announced on 29 December 2021 that new emergency approval procedures now apply to the approval of domestic Class III and imported Class II and Class III medical devices with immediate effect. More

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China Implements Regulations on Self-Inspection for Registration of Medical Devices

18 November 2021

The regulations on self-inspection for registration of medical devices recently released by the National Medical Products Administration took effect on 21 October. The regulations state that applicants who undertake to conduct self-inspection must have the right capabilities and ensure that their inspection results are truthful, accurate, complete and traceable. They must also bear primary responsibility for their self-inspection reports. More

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