Policies
RWS Applicable in GBA: Devices Urgent Use Policy Signed into Law
Guangdong Provincial People’s Congress issued the “Regulation on the Management of the Importation of Drugs and Medical Devices from Hong Kong and Macao into the Nine Mainland Cities of Greater Bay Area” on July 31, 2024, signing the device urgent policy into law. The decree will take effect on December 1, 2024.
A key change in the document is the availability of Real-World Study (RWS) in GBA. Previously, RWS can only be used in Hainan. Article 23 in the new regulations says that designated medical institutions in GBA are encouraged to collaborate with manufacturers to conduct real-world studies. The data from these studies can support for registration and marketing in mainland China. For other highlights in the document, please click HERE
Medical Devices Urgent Use Policy Applicable Nationwide, Not Only in Hainan and GBA
NMPA published the “Management for Temporary Importation and Use of Medical Devices Urgently Needed in Clinical Settings” on July 19, 2024. It green lights the urgent importation and use of medical devices nationwide even if they have not been approved by NMPA.
The document defines the product and medical institution scope, clarify the responsibilities of institutions, enterprises, foreign manufacturers, and agents, and specify application materials, procedures, review methods, and timelines. They apply to the temporary importation of Class II and Class III medical devices urgently needed for clinical use, already available abroad but not domestically, excluding large-scale equipment. For our comprehensive review, please click HERE
Guidelines & Standards
Thirty-Six Standards Issued in One Day
Thirty-six newly established or revised industry standards were released by NMPA on July 10, 2024, to guide manufacturers for type testing, pre-clinical, clinical studies, and regulatory submissions. Impacted devices include forgings and castings for bone and joint prostheses, disposable leukocyte reduction filters, Arterial blood filters. excimer laser refractive surgery system, intraocular illuminators and ophthalmic viscoelastic devices. Click HERE for the full list
PMS & Inspections
Importation Halted for an Italian Orthopedic Company Due to Size Identification Error
NMPA organized a remote inspection of SAMO S.p.A, an Italian orthopedic company. The inspection focused on their artificial knee joint system and cementless artificial hip joint system, the Class III devices. It was found that SAMO had issues such as failing to effectively identify Chinese regulatory requirements and errors in the dimensional parameter identification in PTR. As a result, the NMPA has decided to suspend the import, distribution, and use of the two devices with immediate effect. Please click HERE for more information
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent you for product life cycle without your need to create a local entity in China. Our RA services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and PMS. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.
