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Whether provisional release of imported battery-operated massagers could be denied for want of DCGI approval and an EPR registration certificate was examined. Relying on applicable FAQs, the court held that such massagers, being for wellness/soothing and not therapeutic or disease-alleviation use, do not require approval under the Medical Device Rules, 2017; consequently, the objection based on lack of DCGI approval failed. On EPR compliance, the court noted the relevant public notice permitting filing of EPR applications even post-release, and found that this material was suppressed by the department; hence, the continued detention was unwarranted. The review petitions were dismissed. - HC
Whether provisional release of imported battery-operated massagers could be denied for want of DCGI approval and an EPR registration certificate was examined. Relying on applicable FAQs, the court held that such massagers, being for wellness/soothing and not therapeutic or disease-alleviation use, do not require approval under the Medical Device Rules, 2017; consequently, the objection based on lack of DCGI approval failed. On EPR compliance, the court noted the relevant public notice permitting filing of EPR applications even post-release, and found that this material was suppressed by the department; hence, the continued detention was unwarranted. The review petitions were dismissed. - HC
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