The global medical device industry is rapidly undergoing growth and change making it difficult to keep up with regulations, particularly as each country has its own regulatory requirements. For medical device companies interested in entering a foreign market this requires knowledge of the local regulatory landscape. Among Asian countries, there are recent changes in both China and India.
Medical Devices in 2015
Asian Medical Device | China: New User Fee
Chinese medical device market regulator China Food and Drug Administration (CFDA) has started to enforce new fee requirements. These user fees are in addition to in-country testing, clinical trials, authorized representation and translation services costs. Foreign medical device registrants are required to pay the following fees as of March 2015:
- Initial registration for Imported Class II device registrants fee is $34,000
- Initial registration for Foreign Class III device registrants fee is $49,000
- Registration renewal (every five years) for imported devices fee is $6,500
In accordance with the new system, Chinese regulators will complete initial reviews of Class II registrations within 60 working days and Class III within 90 days. These time frames will not apply in cases where external expert reviews or device-drug combination reviews are required. If CFDA reviewers request additional information, Class II or III applicants have one year to submit the information.
Asian Medical Device | India: Proposal for PSMs
Although India’s market has yet to fulfill its potential, the country’s medical device sector is expected to experience a great deal of growth over the next decade. In the interest of improving the existing framework, India’s Ministry of Health has proposed that the country’s medical device laws be amended to more closely align them with the European Medical Device Directives. The amendments will be submitted for approval in 2015.
The new legislation would simplify import procedures and impact the medical device industry across several areas, including manufacturing, sales, distribution and clinical trials. A newly established Medical Devices Technical Advisory Board will take charge of technical and administrative issues. Among the proposed changes under review -whether foreign companies should have the choice to request a Pre-Submission Meeting (PSM) prior to applying for registration of a medical device in India. Providing this option to registrants will ultimately make the process more transparent, and since it is optional, anyone that prefers to apply directly will still be free to do so.
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