Medical Device Blog – QA & Regulatory Updates from Emergo Group

The Japan Federation of Medical Device Associations (JFMDA) has filed a petition with the country’s Ministry of Health, Labour and Welfare as well as the Pharmaceutical and Medical Devices Agency (PMDA) arguing for more flexible accreditation requirements for foreign device manufacturers that move factories or change names due to mergers or acquisitions.

According to Medtechinsider.com, current law requires foreign manufacturers that relocate factories or change corporate identities to resubmit requests for accreditation. Until those firms are reaccredited, they cannot export products to Japan.

The JMDA has argued that these firms should only have to register their company names, locations and the names of their representatives in order to obtain reaccreditation. Currently, manufacturers must undergo new factory inspections including quality system audits as part of the Japanese reaccreditation process.

Easing the reaccreditation process for foreign medical device manufacturers would provide a more stable supply of medical devices in Japan, contends the JMDA. The association filed the petition as the Japanese government considers how to amend its Pharmaceutical Affairs Law in 2012.

Given that Japan is both one of the largest and most complex medical device markets, any effort to make this market more accessible without compromising safety warrants serious consideration.

The US FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have issued a notice warning of possible effects the ongoing nuclear disaster in Japan may have on medical device components exported to the US.

Although the agency has yet to receive any reports of defective products or adverse events related to devices incorporating Japanese components, the notice expresses concern that possibly deteriorating manufacturing conditions in areas most affected by the tsunami, earthquake and nuclear plant meltdown could compromise safety and effectiveness of devices for export to the US market.

Specific CDRH and CBER concerns include radioactive contamination of device components, especially those derived from animal materials; contaminated water supplies causing device defects; less reliable availability of electrical power disrupting manufacturing processes; compromised sterilization procedures needed for some devices; compromised reliability of product performance, particularly for components such as electrical connectors, microprocessors and sensors; and damaged manufacturing facilities causing supply shortages of components and finished devices.

The notice urges device manufacturers and distributors to take added precautions—increased sampling and more rigorous testing of components and raw materials, for example—in order to ensure safety and effectiveness of their devices in accordance with 21 CFR Part 820.

Additional precautions are also recommended for certification of electronic products and components, including:

• Assessment of incoming devices and supplies to ensure conformity to specifications and quality requirements
• Monitoring of purchasing and acceptance procedures such as inspections and sampling to ensure device and component integrity
• Inspection of device power supplies for water damage
• Running quality control checks to verify product safety
• More thorough assessment of animal-derived products and components such as raw heparin

A complete list of CDRH and CBER recommendations is available on the notice.

If a manufacturer or distributor requires an alternate supplier following these precautionary steps, a Premarket Approval Application Supplement, 21 CFR 814.39 or a new 510(k) for changes to existing devices may be needed. Firms should review 21 CFR Part 807 Subpart B to determine whether they will require alternate suppliers to register and list.

The FDA’s notice comes as European and Australian regulators have also stepped up scrutiny of medical device components and products imported from Japan.

The Japanese government should prioritize power supply allocation to medical device manufacturing facilities producing life-saving and sustaining devices such as ventilators, oxygen supply products and defibrillators.

So argues Kazue Ogino, Japan Federation of Medical Device Associations (JFMDA) chairman, according to the blog medtechinsider.com. Ongoing rolling blackouts throughout the country following the massive earthquake and tsunami earlier this month have spawned production and logistical challenges for manufacturers to ensure adequate supplies of such devices.

Writing to the Japanese health and economic ministries, Ogino requested allowances for additional electricity and gasoline to enable manufacturers to both produce appropriate devices and distribute them to disaster-stricken areas.

The PMDA has just recently released a spreadsheet enumerating the pre-market certificates issued by each of the 12 Registered Certification Bodies (RCBs) sanctioned under the Pharmaceutical Affairs Law (PAL), Article 23. This release was in response to a request from the Ministry of Health, Labor, and Welfare (MHLW) to improve the transparency of the agency.  The data covers the certificates issued for each model of designated controlled medical devices, which are low risk, Class II devices, from April 2008 through November 2009.  It is important to note that as a result of issuing separate certificates for each model, rather than one for each device family, the total number of certificates issued is high: 3,520 during a 19 month period.