Reed Smith Client Alert

Authors: Amy Yin Katherine Yang

Pharmaceuticals, Medical Devices, Health Care & Life Sciences

Medical Devices

CFDA Seeks Public Comment on Special Approval Procedures for Innovative Medical Devices

China Food and Drug Administration (“CFDA,” previously known as “SFDA”) issued a draft Notice on Soliciting Public Comments on the Special Approval Procedures for Innovative Medical Devices for Trial Implementation (“Draft Special Procedures”). The Draft Special Procedures provide for a separate approval process aimed at encouraging the development of qualified, innovative products. According to the Draft Special Procedures, medical device manufacturers and their products must meet the following conditions to qualify for the special approval procedures:

  • The medical device manufacturer must hold the patent right to the medical device on its own, either as the registrant and owner, or as the owner or authorized user, of the relevant invention patent in China through transfer/assignment.
  • The medical device shall have predominant clinical values and incorporate operational principles and functions that are completely new in China, and as compared with leading technologies in other parts of the world. The efficiency or safety of the medical device must be fundamentally improved as compared with similar, existing products.
  • The medical device manufacturer must complete the initial research based on a research process that is accurate and well-controlled. Research data must be complete, with clear sources, to generate a fairly mature product.
  • The medical device manufacturer must be an enterprise incorporated in China, with a valid medical device manufacturing license, and the relevant product must be manufactured in China.

In order to be qualified for the special approval procedures, the Draft Special Procedures appear to require only "Chinese patents, Chinese developer and manufacturing in China" with respect to innovative medical devices. However, the draft provisions do not appear to prevent Chinese subsidiaries of foreign medical device developers from applying for the special approval procedures.

CFDA Allows Manufacturers to Confirm Medical Device Classes

In late March 2013, CFDA issued a Notice Concerning Further Improvement to Defining Classification of Medical Devices. The Notice allows the confirmation of medical device classes by manufacturers, if the manufacturers cannot determine the applicable class for the relevant products. For instance, a company may file an online application with CFDA at either the provincial or central level to confirm the class of a particular medical device described in the application.

ETView Medical, Ltd. Announces CFDA Clearance of Pre-Marketing Notification Application for the VivaSight-SL Line of Innovative Airway Devices (Business Wire 2013-03-18)

ETView (TASE: ETVW), a manufacturer of airway tubes, announced that it has received clearance of a Pre-Marketing Notification Application from CFDA. The company expects to enter the Chinese market with its product, VivaSight-SL, immediately. VivaSight-SL, a single-use airway tube with an integrated high-resolution camera, will be exclusively distributed throughout China by the China National Pharmaceutical Group Corporation (SINOPHARM). Additional pre-market regulatory clearances worldwide are anticipated for the year 2013.


Executives Call for Pharmaceutical Reform (China Daily 2013-03-06) – March 6, 2013

A group of Chinese pharmaceutical business executives, who are also deputies of the National People's Congress and members of the Chinese People's Political Consultative Conference, recently proposed that China should cancel the government-led bidding system on the medicines purchased by public hospitals to, among other things, reduce drug costs and eliminate the potential for corrupt activities. Citing the complicated procedures and numerous departments involved within the current government-led bidding system, the executives urged instead for a market-oriented mechanism to be implemented under strict and standardized government supervision. The executives also suggested eliminating the special treatment afforded to the expired patents of foreign drug manufacturers.

213 New Varieties of Drugs Added into National Essential Drug Catalogue (People’s Daily Online 2013-03-18)

On March 15, 2013, the Ministry of Health ("MOH") issued the 2012 National Essential Drug Catalogue, effective May 1, 2013. The new catalogue standardizes the formula specification and covers more varieties of drugs. The catalogue now covers a total of 520 varieties of drugs, including 317 types of chemicals and biological products, and 203 types of Chinese patent medicines, representing an increase of 213 varieties since the issuance of the original catalogue. Among the new varieties are nearly 200 are for children’s drugs. In addition, the catalogue has included an antineoplastic drug as a new category, which includes 26 varieties of drugs.

MOH and CFDA Solicit Public Comments on Clinical Research on Stem Cells (Ministry of Health 2013-03-07)

The MOH and CFDA jointly issued draft regulations for public comment regarding clinical experiments on stem cells. These regulations include the Administrative Measures on Clinical Test and Research of Stem Cells for Trial Implementation, the Administrative Measures on Clinical Test and Research Bases of Stem Cell for Trial Implementation, and the Guiding Principles for Quality Control and Preclinical Studies for Trial Implementation. 

Govt. to Increase Funding for Medical Reform (China Daily 2013-03-15) – March 15, 2013

According to Wang Bao'an, Vice-Minister of Finance, the government has spent more than 2.2 trillion yuan ($354 billion) on expenditures related to health care reform, accounting for 5.7 percent of the total government spending. The government plans to increase spending to support the ongoing reform efforts. China launched its health care reform efforts in 2009, and seeks to make health care affordable and accessible for all citizens by 2020.


Advisers Seeking a Remedy for Private Hospitals (China Daily 2013-03-07) – March 7, 2013

At the 12th annual session of the CPPCC National Committee, Huang Jiefu, Vice-Minister of Health, called for increased government support for the development of private hospitals in order to foster a larger medical market. The increased opportunities will also enable China to meet the rising public demand for quality medical services.

Xiamen Encourages Medical Cooperation (China Daily 2013-03-12)

The government of Xiamen, a coastal city in Fujian province, intends to take advantage of its geographic proximity with Taiwan to serve as a pioneer in hosting hospitals that are wholly Taiwan-invested. According to Chen Zixuan, Vice-Chairwoman of Fujian’s Committee of the Taiwan Democratic Self-Government League, "The city could become an ideal way to raise cross-Straits medical cooperation to a new level." Currently there are around 4,000 Taiwan-funded enterprises in Xiamen. Moreover, it is reported that more than 100,000 Taiwanese people currently living in Xiamen prefer to be treated at hospitals that have a Taiwanese background.

Online Outpatient Appointments to End Misery of Queuing for Hours (Shanghai Daily 2013-03-19)

Instead of queuing for hours at hospitals for outpatient appointments, local residents in Shanghai may soon make outpatient appointments through the Internet. Officials with the Shanghai Health Bureau announced that a health information network is expected to cover the city's 600 public hospitals by June 2013. Moreover, patient records, such as reports of recent diagnoses and health checks, may be uploaded to the website and viewed by doctors of all hospitals in the city.

China to Clean Up Grassroots Medical Institutions (Xinhua News Agency 2013-03-23)

According to a recent statement released by the National Health and Family Planning Commission ("NHFPC"), health authorities have vowed to overhaul and restore grassroots medical institutions in an effort to increase and maintain quality and safety. Grassroots medical institutions in China include county-level hospitals, community health centers, infirmaries, and clinics. During this initiative, relevant information, such as data related to registration, approval and management of the grassroots medical institutions, will be gathered, screened, and ultimately stored in an electronic archive.

Singapore Market

Clearbridge BioMedics Raises $7.2 Million Funding ( 2013-03-14)

Clearbridge BioMedics, a Singapore-based company that specializes in developing medical devices with applications in oncology research and diagnostics, recently announced that it has completed a new $7.2 million (S$9 million) financing round. The new funding round will be used to further develop the company’s proprietary ClearCell System, which is one of the first non-biomarker-based systems commercially available to effectively detect, isolate and retrieve circulating tumor cells ("CTCs") from blood. Vertex Venture Holdings, Ltd. led the new funding round, and other investors include SPRING Seeds Capital, Clearbridge BSA Pte Ltd., Mr. Lu Yoh Chie, and existing shareholder BioVeda.


Client Alert 2013-108