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Medical Device Blog – QA & Regulatory Updates from Emergo Group
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.
Chinese Medical Technology Market Primed for 17% Growth According to Citigroup
A new Citigroup Global Markets report on China’s medical device and technology industries expects the market to reach $5 billion in 2012, due primarily to increased hospital purchasing budgets, government investments in hospital upgrades and expansion, and robust hospital construction cycles in China through 2015.
Citi surveyed 383 Chinese hospitals across 29 provinces, and examined 11 medical equipment segments such as Magnetic Resonance Imaging (MRI), ultrasounds, tomography devices and radiography devices.
Leading segments
The report identified MRI, computed tomography, color ultrasound and digital radiography as the largest medical device segments in China, with health growth prospects; black-and-white ultrasound device purchasing, on the other hand, is expected to decline going forward.
Market dominated by foreign manufacturers
The Citi report also found that multinational medical device manufacturers continue to dominate the Chinese market across 10 of the 11 segments examined. Only in the patient monitoring device sector do domestic firms outnumber foreign ones. This trend will likely continue, as well: more than 80% of hospital respondents to Citi’s survey indicated a preference for multinational medical equipment when it comes to purchasing. Foreign manufacturers with sizeable Chinese market share include GE, Phillips, Siemens, while the biggest domestic firms include Mindray, Wangdong and Aeon.
China Allows Clinical Trial Waivers for Some Class II Medical Devices
Update 12/20/2011: According to Emergo Group sources in Beijing, the waiver policy was instituted by the Beijing FDA (BFDA) rather than the SFDA. Furthermore, the policy applies only to domestic medical devices in China, not imports.
China’s State Food and Drug Administration (SFDA) has waived local clinical trial requirements for 21 types of Class II medical devices equivalent to products currently on the Chinese market.
To qualify for the waiver, applicants must provide SFDA authorities with “comparative illustrations” of how their devices are equivalent to devices already approved in China. Evidence of equivalence should include data about a device’s functionality, manufacturing materials and composition, and technical performance indicators. Information regarding a device’s sterilization methods, expected uses and household uses should also be included.
The types of devices eligible for the waiver include:
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In place since late November, the SFDA’s new policy should streamline many Class II device manufacturers’ paths to market in China.
Markets: ChinaTags: China, clinical trial, medical device, SFDA
Author: Stewart EisenhartDate: December 19, 2011
Health Canada Elaborates on IEC 60601-1 Compliance Recommendations
Health Canada has provided recommendations for medical device manufacturers whose products must comply with the latest iteration (Third Edition) of the IEC 60601-1 medical electrical equipment safety standards.
According to an HC official, licenses already issued for medical devices meeting requirements of the Second Edition of IEC 60601-1 will remain valid after 2012, as will licenses for devices in compliance with standards related to the Second Edition.
New equipment, however, may have to meet Third Edition requirements—even if manufacturers already hold licenses for compliance with the Second Edition—depending on how individual provinces enforce Canada’s Electrical Safety Code.
From June 2012, manufacturers applying for significant change amendments to their device licenses previously complying with the Second Edition will be asked to update their compliance to meet Third Edition requirements, according to the official. The regulator also encourages all manufacturers to comply with the Third Edition as quickly as possible to ensure up-to-date electrical safety of their products.
Markets: Canada, ChinaTags: Health Canada, IEC 60601-1
Author: Stewart EisenhartDate: July 1, 2011
Device Recall Regulations Set to Take Effect in China
China’s State Food and Drug Administration (SFDA) will implement new medical device recall regulations on July 1.
The Provisions for Medical Device Recall (interim) include 38 articles covering the supervisory system for device recalls, classification and categories of recalls as well as legal liability issues. The provisions are intended to hew closely to international conventions regarding core issues, and incorporate procedures already put in place for China’s drug recall system. Also included in the provisions are more specialized regulations to better target issues surrounding medical devices.
Markets: ChinaTags: China, medical device, recall, SFDA
Author: Stewart EisenhartDate: June 23, 2011
