On May 26th, CFDA issued a guideline of shelf validity period for passive implantable medical device.This guideline is a general requirement for passive implantable medical equipment shelf validity period and does not address other technical requirements.
The guideline is the revised version of “Passive Implantable Medical Device Shelf Life Registration Guideline” (CFDA, 2011)
Highlights of this revision:
1) Changed “Shelf Life” to “Shelf Validity Period”
2) Adjusted some wording
3) Modified the definition of implanted medical equipment, consistent with the definition in "Medical Device Classification Regulation" (CFDA, No. 15).
According to Article 29 in the “Administrative Decree for the IVD Reagents Registration” (CFDA, No. 5), the clinical exempt IVD reagents will need the clinical performance evaluation based on the assessment of products’ intended use, interference factors, comprehensive literature review and other non-clinical-trial methods.
On May 11, 2017, the Standards Regulation Center in Beijing organized a meeting on how to prepare training materials for the new and pending release "Medical Device Classification Directory". The leaders from CFDA and the Standards Regulation Center along with the responsible people for the sub-directory revised work units, more than 50 people attended the meeting. CFDA commissioner, Wang Lanming, attended the meeting and talked about the importance of thoroughly prepare the training materials for the implementation of the new Medical Device Classification Directory.
CFDA "Medical Device Classification Directory (revised) " was issued for feedback with due date on November 25, 2016.
The revised medical device classification directory has significant implications for medical devices registrations or renewals. If your devices are not included in the revised directory, you must go through the expert panel forum to get the proper classification. Expert panel could be time-consuming and costly
This newly released revised draft directory has been in the works for the past seven years. It was finally released for industry feedback. The previous directory was released in 2002. It is very dated and lacks details and clarity. It fails to keep up with the rapid proliferation of medical devices and the growth of complex technologies that have taken place in China.
The revised directory has 22 subdirectories. It consolidated and reduced the 2002 version’s 43 subdirectories by 19. Under each of the 22 subdirectories, there are further detailed divisions. Here are a few examples of how to look at the categories.
Grace Fu Palma, founder and CEO of Boston-based China Med Device (http://www.ChinaMedDevice.com), a firm specializing in commercialization and funding for U.S. medtech companies entering China, offers new updates on CFDA clinical trial reform in China by CFDA. China Med Device specializing in providing turn-key solution for medtech companies, brings you up to date information on CFDA. If you have any feedback, please e-mail to email@example.com.
On May 11, 2017, the State Food and Drug Administration issued a notice (Opinion No. 53 of 2017) on the "Policy on Encouraging the Reform of Clinical Trials of Drugs and Devices Innovations" (draft). The "draft" is to further deepen the review and approval system reform, promote the pharmaceutical and medical device industries restructuring and technological innovation, improve industrial competitiveness, and to meet the public needs.
1. Accreditation approval to letter to file: the clinical trial institution qualification approval has been changed from the original accreditation process by CFDA to a simple letter to file at the designated registration website. The reform intends to encourage social capital investment to set up clinical trial institutions and to provide clinical trial professional services. The main investigators should have a senior title and have participated in more than three clinical trials. Clinical trial Applicants may employ a third party to evaluate the accreditation of the clinical trial institution. The supervision and validation will be shifted on-site inspection by CFDA officials. The inspection results will be announced to the public. Failure to pass the examination of the clinical trial project, the relevant data will be rejected by CFDA.
We are monitoring closely the current initiative taken by CFDA to reform its registration and regulatory policies and believe this reform should positively impact medical device entry to China by US and international medtech companies:
On May 11, the CFDA released three documents for public comment aiming to reform clinical trial management; accelerate review and approval process; and implement full life-cycle management; for encouraging pharmaceutical and medical device Innovation. These three documents mark a big step forward for the CFDA in reforming the registration system for pharmaceutical and medical devices and reflect some of the major issues that the industry has been advocating on for decades. On May 12, the CFDA further released Policies on Protecting Innovator’s Interests for Encouraging Pharmaceutical and Medical Device Innovation, to establish a pharmaceutical patent linkage system and improve test data protection system. The systems and measures proposed in this draft provide more detailed regulations for enforcing existing measures, showing the CFDA’s determination in further strengthening IPR protection and creating an atmosphere that rewards innovation...