Product Compliance
Test/Filing/Registration
Product Compliance
Test/Filing/Registration
Issued by the State Food and Drug Administration Support Hong Kong and Macao medical device registrants in the mainland of Dawan District9Implementation plan for municipal production of medical devices Notification of Guangdong Provincial Drug Administration enclosure 1. Support Hong Kong and Macao drug marketing license holders in the mainland of Dawan District9Municipal Drug production implementation plan enclosure 2. Support Hong Kong and Macao medical device registrants in the mainland of Dawan District9Implementation plan for municipal production of medical devices General Department of the State Food and Drug Administration 2022year6month23day |
enclosure2
Support Hong Kong and Macao medical device registrants in the mainland of Dawan District9Implementation plan for municipal production of medical devices
To implement Work plan for innovative development of drug and medical device supervision in Guangdong Hong Kong Macao Greater Bay District in Carry out the reform of medical device registrant system in Guangdong Hong Kong Macao Greater Bay District Relevant requirements,Support Hong Kong and Macao medical device registrants to place their medical devices in the mainland of Guangdong, Hong Kong and Macao Greater Bay area9Production of qualified enterprises in the city hereinafter referred to as Hong Kong and Macao medical device registrants Cross border commissioned production .After research,The work plan is formulated as follows
one Work objectives
Guided by Xi Jinping's thought of socialism with Chinese characteristics for a new era, ,According to the Party Central Committee The State Council's decision-making and deployment and the State Administration of market supervision, etc8Issued by Department Work plan for innovative development of drug and medical device supervision in Guangdong Hong Kong Macao Greater Bay District Relevant regulations,Deepen the reform of medical device registrants,Allow Hong Kong and Macao medical device registrants to commission cross-border production,Further promote the deep integration of biomedical industry in Guangdong Hong Kong Macao Greater Bay Area,Realize the common development of pharmaceutical industry in Guangdong, Hong Kong and Macao Greater Bay Area.
two Division of responsibilities
The State Food and drug administration is responsible for the approval of the change of the registration certificate of medical devices in Hong Kong and Macao.
Guangdong Provincial Food and drug administration is responsible for the production license of medical devices involved in cross-border commissioned production by Hong Kong and Macao medical device registrants,And organize the verification of medical device registration quality management system,And implement the territorial supervision responsibility,Strengthen the supervision and inspection of relevant enterprises within the jurisdiction.
three Scope of application
one Variety range It is applicable to the holding and production of enterprises legally registered in the Hong Kong Special Administrative Region or the Macao Special Administrative Region,And has obtained Medical instrument registration certificate Medical devices registered and listed in China. Catalogue of prohibited commissioned medical devices SFDA circular2022Year17number Except for specified varieties.
two Applicable enterprise The medical device registrant is a Hong Kong and Macao enterprise,The foreign-invested enterprise legal person established in the mainland of Dawan district shall be the agent,Handle the registration change of medical devices,Assist Hong Kong and Macao medical device registrants in fulfilling their obligations,Bear joint and several liability.
After the medical device registrants in Hong Kong and Macao obtain the medical device registration certificate issued by the State Food and drug administration,Can entrust the mainland of Dawan District9Production of qualified enterprises in the city.The entrusted manufacturing enterprise shall have a quality management system and production capacity suitable for the medical devices it produces.
four Working procedure
one Identify domestic agents.Hong Kong and Macao medical device registrants are represented by foreign-invested enterprise legal persons established in the mainland of Dawan district,Handle the registration change of medical devices,Assist Hong Kong and Macao medical device registrants to perform Regulations on the supervision and administration of medical devices Article 20 obligations,Bear joint and several liability.The agent shall be the same as the agent listed in the medical device registration certificate held by the Hong Kong and Macao medical device registrants.
two Sign the commissioned production agreement.The registrant of Hong Kong and Macao medical devices is in the mainland of Guangdong, Hong Kong and Macao Greater Bay area9The city selects qualified enterprises as entrusted production enterprises,Refer to the guidance requirements of the quality agreement for commissioned production of medical devices formulated by the State Food and drug administration,By Hong Kong and Macao medical device registrants The agent and the entrusted production enterprise jointly sign the quality agreement and entrustment agreement,Supervise the entrusted production enterprise to perform the obligations agreed in the relevant agreement.
three Change the manufacturing address of the medical device registration certificate.The agent assists the Hong Kong and Macao medical device registrants to submit qualified application materials to the State Food and drug administration.The device audit center of the State Food and drug administration shall carry out the review and approval work in accordance with the procedures.Guangdong Provincial Food and Drug Administration in accordance with the relevant requirements of medical device registration quality system verification Organize and carry out on-site system verification according to the requirements of the production quality management specification and its appendix.After technical review and verification of registered quality system,Satisfactory,Approval of change of registration,grant Medical device change registration document ,Specify the name of the entrusted production enterprise Production address, original registration certificate number and other information.
four Entrusted production enterprises perform reporting obligations.After the Hong Kong and Macao medical device registrants complete the change of medical device registration certificate,The commissioned production enterprise shall report to the Guangdong food and drug administration to increase the variety of products produced,And provide the entrusting party Commissioned products Entrusted period and other information.
five Declaration materials
according to Announcement on publishing the requirements of medical device registration application materials and the format of approval documents Announcement of the State Food and Drug Administration2021Year121number and Announcement on publishing the requirements for registration and application materials of in vitro diagnostic reagents and the format of approval certificates Announcement of the State Food and Drug Administration2021Year122number Relevant requirements for submission of change registration application materials.
six Implementation basis
Regulations on the supervision and administration of medical devices Administrative measures for registration and filing of medical devices Administrative measures for registration and filing of in vitro diagnostic reagents Measures for the supervision and administration of medical device production Work plan for innovative development of drug and medical device supervision in Guangdong Hong Kong Macao Greater Bay District etc..
seven Registration fee
The charging standard of medical device registration is in accordance with Notice of the State Food and Drug Administration on the release of drugs Announcement on the charging standards for the registration of medical device products 2015year53number Request execution.
eight Job requirements
one Cross border commissioned medical devices produced by Hong Kong and Macao medical device registrants,In principle, it should be consistent with the relevant matters specified in the medical device registration certificate and its attachments,Its main raw materials and production process should not be changed,The quality management system for domestic production of products shall be equivalent to that for overseas production.
two The registrants of medical devices in Hong Kong and Macao shall strictly implement the main responsibility for the quality management of the whole life cycle of medical devices,according to Regulations on the supervision and administration of medical devices Measures for the supervision and administration of medical device production Etc,Establish and improve the quality management system and ensure its effective operation,Earnestly implement the whole process quality management Obligations of adverse event monitoring and product recall.
three Hong Kong and Macao medical device registrants in the mainland of Dawan District9Violation of the production and operation behavior of the city Regulations on the supervision and administration of medical devices And supporting rules and regulations,The registrant shall bear the main responsibility,The agent shall be jointly and severally liable,The entrusted production enterprise shall bear corresponding legal liabilities.Hong Kong and Macao medical device registrants The agent shall conduct self inspection on the operation of the quality management system every year,And in the following year3month31Recently, the self inspection report was submitted through the online platform of the provincial food and drug administration.
four Guangdong Provincial Food and Drug Administration in accordance with Problem orientation,Risk prevention,Clear responsibility Principle of,Innovate the supervision mode of medical devices,Explore with Hong Kong and Macao regulatory authorities to establish a smooth flow of information Orderly connection A cooperative and powerful supervision mechanism,Improve the supervision system during and after the event,Enhance regulatory synergy.Consolidate the full life cycle quality management responsibility of medical devices of Hong Kong and Macao registrants,Supervise the development of the agent production management Safety of traditional Chinese medical instruments in the whole process of use Validity bear joint and several liability according to law,Strengthen the supervision and inspection of relevant production activities of entrusted production enterprises,Strengthen the sampling inspection of relevant product quality and adverse event monitoring,Improve the ability of analysis and early warning,Effectively prevent the safety risks of medical devices.
nine Other matters
one Hong Kong and Macao medical device registrants can register in the mainland of Dawan district9A number of qualified enterprises in the city carry out commissioned production,The handling procedure is the same as above.
two Hong Kong and Macao medical device registrants cancel cross-border commissioned production,The original commissioned production enterprise shall30Report to Guangdong food and drug administration within days.
three On the marketing of medical devices commissioned by Hong Kong and Macao medical device registrants,Led by Guangdong Provincial Food and Drug Administration and customs Tax Communication with foreign exchange management and other departments,Assist enterprises to implement convenient cross-border settlement methods in accordance with the law.
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