Blog

June 14, 2017

CFDA issued the revised version of “Passive Implantable Medical Device Shelf Validity Period Registration Guideline”

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).

June 14, 2017

China CT Medical Equipment Market Growing at a Rapid Pace

According to the 2016 China CT Medical Equipment Market Research Reportpublished by the Chinese Association of Medical Equipment in May 2017, the CT market ownership (the number of the registered […]
June 14, 2017

China In-Vitro Diagnostics (IVD) Market Expected to Triple by 2022

IVD China MarketChina In-vitro diagnostics market is expected to be tripling its market size by the end of 2022 from 2016, according to a new report published by Research And […]
June 8, 2017

NuvOx Pharma, a China Med Device Client, Has Won the 1st Place As The Most Valuable Start-Up Company

Congratulations to NuvOx Pharma, a China Med Device client, for winning the 1st place of the start-up companies with the most investment value, out of 46 biopharma companies at the […]
June 6, 2017

CFDA Updates: Draft of “Clinical Evaluation Basic Requirements for Clinical Exempt IVD Reagents” Issued, Along with the 2nd Batch of Clinical Exempt Class II IVD Reagents

On May 24,2017, CFDA issued the draft of “Clinical Evaluation Basic Requirements for Clinical Exempt IVD Reagents”. The 2nd batch of clinical exempt class II IVD reagents (130 reagents) have […]
June 6, 2017

CFDA Updates: Clinical Evaluation Requirements for Clinical Trial Exempt IVD Reagents (Draft)

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.

May 31, 2017

CFDA Update: More On Overseas On-site Inspections

Under CFDA Guideline Nos 14 and 218 issued in 2015, China targets sterile devices, implant and IVDs for overseas onsite inspection for registration and issuing manufacturing permit, including change order […]
May 30, 2017

Market Segment – China’s Overall Dental Market Annual Growth Rate Is 20-30%

Market Segment Snapshot:China’s overall dental market annual growth rate is at 20-30% with the implants annual growth rate goes an even faster pace at >30%. China Med Device https://chinameddevice.com/ performed […]
May 30, 2017

CFDA New Medical Device Classification Directory Will Be Released Soon

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.

May 30, 2017

Grace’s Column: CFDA to Ease Rules For Clinical Trial Certification, Overseas Data

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 info@chinameddevice.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.

May 25, 2017

Chinese Premier Signed a State Council Order for the Modification of China Medical Device Regulation Policy

China’s Premier Li Keqiang just signed the State Council Order No. 680, announcing the Decision on Modification of “Medical Device Regulation Policy” by the State Council, effective immediately. The State […]
May 25, 2017

CMD Hails CFDA’s Policy Reform Initiative

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...