The AHWP framework targets greater coordination with the APEC Regulatory Convergence for Medical Products, which pushes greater regulatory convergence among APEC members by 2020, and the ASEAN Medical Device Directive (AMDD), which would establish a single medical device regulatory community among ASEAN member states by 2015.

The State Food and Drug Administration (SFDA) of China has set new ruleseffective January 1, 2013 that would mete out more severe punishment to medical device and pharmaceutical manufacturers for certain violations. The SFDA notice lists several violations that warrant more aggressive enforcement of China’s Administrative Punishment Law applied to drugs and medical equipment, while at the same time granting local and regional officials more discretion in determining penalties for violators. Violations warranting more severe penalties include production and sale of counterfeit or substandard medical devices that cause injury; production of counterfeit or substandard devices by companies found previously to have committed similar violations; and avoiding SFDA supervision or inspection or tampering with evidence that would incriminate the company in question.

The Pakistani government has signed into law legislation to formally regulate medical devices and pharmaceutical...

Medical device manufacturers interested in selling their wireless products internationally face two sets of regulatory hurdles: medical and wireless.

India’s Central Drugs Standard Control Organization (CDSCO) has published new guidance documents covering registration and re-registration of notified medical devices, as well as guidances for manufacturing and import licensing. Based on an initial analysis by Emergo Group, the medical device registration process in India generally remains the same. However, manufacturers should bear in mind several small changes:

Emergo Group has learned that Malaysian authorities have closed their voluntary registration system for medical device manufacturers in preparation for the launch of a mandatory registration scheme expected in 2013.

In addition to recent draft regulations concerning medical devices and in vitro diagnostics, the European Commission has drafted additional reforms (“PIP Action Plan”) aimed specifically at greater control of Notified Bodies. The draft Regulation on Designation and Supervision of Notified Bodies and Recommendations for Audits and Assessments have been drawn-up by means of the Standing Committee-mechanism described in Article 7 of the MDD 93/42/EEC (and Article 6 of the AIMDD 90/385/EEC). Therefore, these changes are expected much sooner than the impending legislative revisions. The Commission documents are expected to be released before the end of 2012 and the changes will likely be implemented as soon as 2013.

Health ministers of Australia and New Zealand report progress toward launching a joint regulatory body for oversight of medical devices in both countries. Once operational, the new system will replace both the Australian Medicines and Medical Devices Safety Authority .

The US Food and Drug Administration has published a new report showing small but consistent...

New guidance published by the US Food and Drug Administration advises manufacturers of “home use” medical devices on how to ensure compliance with safety and effectiveness requirements when designing their products.