Summary of the key points:
The newly revised Regulations on Medical Device Supervision and Administration will be launched in 2019.
Product testing may not be required to be done by the NMPA-certified testing center.
Due to the uncertainty in the current policy, it is still unclear that whether this change can be implemented or not.
The newly revised Regulations on Medical Device Supervision and Administration will be launched in 2019. Referring to the "Amendment of the Medical Device Supervision and Administration Regulations (Draft for Review)" issued in 2018, there will be a big change in the revised version compared to the version currently in effect, that is, the product testing is not required to be done by the NMPA-certified testing center. This change means that the company is no longer required to go to the NMPA-certified medical device testing center for product testing.
The product testing refers to the process of the medical device testing center evaluates the Product Technical Requirements (PTR) of the product submitted by the applicant and the integrity and accuracy of the medical device. If the applicant's medical device is the Class I, then it is only necessary to provide a self-test report when filing the application and does not need to pass the product testing. If the applicant applies for the registration of Class II and Class III medical devices, then a product testing is required. Applicants need to select a medical device testing center with inspection qualification according to their own products. The medical device testing center is authorized by NMPA.
CIRS believes that this alteration can speed up the review process for companies. Due to the rapid development of medical devices, many new technologies have emerged. The medical device testing center may not know the product and will waste a lot of time during the pre-inspection preparation phase. And because there are too many products to be inspected, it will inevitably lead to a backlog, which will also waste a lot of time. Companies with self-inspection capabilities have a clear understanding of the strengths and weaknesses of the product, which will also help to save a lot of time during inspections. However, due to the uncertainty in the current policy, it is still unclear that whether this change can be implemented or not. At the same time as the cancellation of the mandatory requirement for the company to conduct product testing at the NMPA-certified testing center, the requirements for the third-party testing organization have not been formed, and there is no supporting scheme for the certification, supervision and management of the third-party testing organization. Meanwhile, companies are also more inclined to conduct product testing at NMPA-certified testing center. Therefore, there is still uncertainty about whether this change can be implemented this year.
CIRS recommends that in order to be prepared for the newly revised "Medical Device Supervision and Management Regulations", companies need to ensure self-inspection capabilities, improve the self-inspection system, and designate a department responsible for product safety and technical requirements supervision. Moreover, due to the uncertainty of regulatory policies, we recommend going to the NMPA-certified testing center for product testing.
China Medical Device Regulation Related Resources provided by CIRS:
China NMPA Medical Device Filing and Registration Consulting
Clinical Trial Consulting
Medical Device GMP System Assessment
China Medical Device Regulation Training
Guideline: Medical Device Registration in China
Annual Report: Medical Device Market in China