The variety of "Hong Kong Macau Medical Device Connect" has been expanded to 67
Date：Aug 04,2024 Information source：Internet
On July 31, the 11th meeting of the Standing Committee of the 14th Guangdong Provincial People''s Congress voted to pass the "Regulations on the Administration of Imported Drugs and Medical Devices from Hong Kong and Macao in Nine Mainland Cities of the Guangdong Hong Kong Macao Greater Bay Area" (hereinafter referred to as the "Regulations"). The Regulation consists of 30 articles, which adhere to serving the people''s livelihood through "small incisions" and will come into effect on December 1, 2024.
The author learned from the Guangdong Provincial Drug Administration that since the implementation of the "Hong Kong Macau Medical Device Connect" policy, as of June this year, Guangdong Province has approved a total of 19 designated medical institutions. The variety of "Hong Kong Macau Medical Device Connect" has expanded to 67 (including 34 drugs and 33 medical equipment), benefiting more than 7000 patients and effectively meeting the urgent clinical needs of the public for medication and medical devices.
The Regulation has systematically sorted out the difficulties, pain points, and obstacles encountered by Guangdong Province since the implementation of the "Hong Kong Macao Drug and Device Connect" policy. It will strengthen the coordination and cooperation between drug supervision and management, health, medical security and other departments, construct a full process supervision mechanism covering the application, procurement, import, distribution, and use of urgently needed Hong Kong and Macao drugs and devices, optimize the management system of the urgently needed Hong Kong and Macao drug and device catalog, simplify the review procedures, accelerate the review speed, and turn "people waiting for drugs" into "drugs waiting for people".
Among them, Article 11 stipulates that pharmaceutical and medical equipment operating enterprises engaged in the procurement, import, and distribution of urgently needed Hong Kong and Macao pharmaceutical and medical equipment should have the qualifications for pharmaceutical and medical equipment operation and import and export operation, possess corresponding modern logistics conditions and distribution capabilities, and be able to trace the entire process of urgently needed Hong Kong and Macao pharmaceutical and medical equipment. At the same time, according to the Regulations, it is necessary to standardize the management of the use of urgently needed Hong Kong and Macao drugs and equipment, establish systems for alert, recall, and traceability of urgently needed Hong Kong and Macao drugs and equipment, and clarify departmental regulatory measures.
It is worth noting that Article 8 of the Regulation compresses the review time limit for applying for the import and use of drugs and medical equipment in the urgently needed Hong Kong and Macao drug and equipment catalog to "five plus five" (10 working days), and the review time limit for applying for the import and use of drugs and medical equipment outside the urgently needed Hong Kong and Macao drug and equipment catalog to "ten plus ten" (20 working days). It also specifically stipulates that the Guangdong Provincial Drug Supervision and Administration Department and the Provincial Health Administration should simplify the review process and compress the review time limit through online acceptance, parallel review, and other methods.
In addition, due to the urgent need for drugs and equipment from Hong Kong and Macau, which are mainly self funded drugs, the burden on patients is relatively high. In response, the Regulation improves the relief system and introduces insurance mechanisms. Article 22 encourages insurance institutions to develop insurance products that cover urgently needed drugs and equipment from Hong Kong and Macao, optimize insurance compensation procedures, and protect the legitimate rights and interests of patients; Encourage the inclusion of urgently needed drugs and equipment from Hong Kong and Macau in universal commercial health insurance, and support the use of personal accounts for basic medical insurance to purchase universal commercial health insurance.
Source: Southern Daily News
The author learned from the Guangdong Provincial Drug Administration that since the implementation of the "Hong Kong Macau Medical Device Connect" policy, as of June this year, Guangdong Province has approved a total of 19 designated medical institutions. The variety of "Hong Kong Macau Medical Device Connect" has expanded to 67 (including 34 drugs and 33 medical equipment), benefiting more than 7000 patients and effectively meeting the urgent clinical needs of the public for medication and medical devices.
The Regulation has systematically sorted out the difficulties, pain points, and obstacles encountered by Guangdong Province since the implementation of the "Hong Kong Macao Drug and Device Connect" policy. It will strengthen the coordination and cooperation between drug supervision and management, health, medical security and other departments, construct a full process supervision mechanism covering the application, procurement, import, distribution, and use of urgently needed Hong Kong and Macao drugs and devices, optimize the management system of the urgently needed Hong Kong and Macao drug and device catalog, simplify the review procedures, accelerate the review speed, and turn "people waiting for drugs" into "drugs waiting for people".
Among them, Article 11 stipulates that pharmaceutical and medical equipment operating enterprises engaged in the procurement, import, and distribution of urgently needed Hong Kong and Macao pharmaceutical and medical equipment should have the qualifications for pharmaceutical and medical equipment operation and import and export operation, possess corresponding modern logistics conditions and distribution capabilities, and be able to trace the entire process of urgently needed Hong Kong and Macao pharmaceutical and medical equipment. At the same time, according to the Regulations, it is necessary to standardize the management of the use of urgently needed Hong Kong and Macao drugs and equipment, establish systems for alert, recall, and traceability of urgently needed Hong Kong and Macao drugs and equipment, and clarify departmental regulatory measures.
It is worth noting that Article 8 of the Regulation compresses the review time limit for applying for the import and use of drugs and medical equipment in the urgently needed Hong Kong and Macao drug and equipment catalog to "five plus five" (10 working days), and the review time limit for applying for the import and use of drugs and medical equipment outside the urgently needed Hong Kong and Macao drug and equipment catalog to "ten plus ten" (20 working days). It also specifically stipulates that the Guangdong Provincial Drug Supervision and Administration Department and the Provincial Health Administration should simplify the review process and compress the review time limit through online acceptance, parallel review, and other methods.
In addition, due to the urgent need for drugs and equipment from Hong Kong and Macau, which are mainly self funded drugs, the burden on patients is relatively high. In response, the Regulation improves the relief system and introduces insurance mechanisms. Article 22 encourages insurance institutions to develop insurance products that cover urgently needed drugs and equipment from Hong Kong and Macao, optimize insurance compensation procedures, and protect the legitimate rights and interests of patients; Encourage the inclusion of urgently needed drugs and equipment from Hong Kong and Macau in universal commercial health insurance, and support the use of personal accounts for basic medical insurance to purchase universal commercial health insurance.
Source: Southern Daily News