Wellness massagers and post-release EPR compliance cannot, by themselves, block provisional import release or justify review.

Imported massagers meant only for soothing or general wellness were treated as wellness products, not as therapeutic medical devices, so approval under the Medical Devices Rules, 2017 was not required. The absence of an Extended Producer Responsibility registration certificate did not, by itself, bar provisional release where the applicable public notice allowed the application to be filed after release and an application had already been made in one instance. Review was refused because no ground for reconsideration was shown, the objections were already available earlier, similar consignments had been cleared, and the earlier release direction was maintained with costs imposed on the Customs Department.

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Issues: (i) Whether imported massagers used for soothing or wellness purposes required approval under the Medical Devices Rules, 2017. (ii) Whether the absence of an Extended Producer Responsibility registration certificate justified denial of release, when the certificate could be applied for after release under the applicable public notice. (iii) Whether the review petitions seeking reconsideration of the earlier order disclosed any ground for review.

Issue (i): Whether imported massagers used for soothing or wellness purposes required approval under the Medical Devices Rules, 2017.

Analysis: The materials relied upon showed that massagers intended only for soothing or general wellness purposes do not fall within the regulatory ambit applicable to therapeutic devices or products intended for alleviation of disease or disorder. The imported goods were treated as wellness products rather than medical devices requiring regulatory approval.

Conclusion: No approval under the Medical Devices Rules, 2017 was required for such massagers.

Issue (ii): Whether the absence of an Extended Producer Responsibility registration certificate justified denial of release, when the certificate could be applied for after release under the applicable public notice.

Analysis: The public notice was read as permitting filing of the EPR certificate application even after release of the goods. It was also noticed that an application had in fact been filed in respect of one of the petitioners. On that basis, absence of the certificate at the pre-release stage could not be treated as a complete bar.

Conclusion: The EPR certificate requirement did not justify withholding provisional release where the application could be filed after release.

Issue (iii): Whether the review petitions seeking reconsideration of the earlier order disclosed any ground for review.

Analysis: The Court found no merit in the review, noting that the objections now pressed had already been available earlier, that similar consignments had been cleared, and that the respondents had no satisfactory answer to the selective enforcement grievance. The earlier order therefore did not warrant review.

Conclusion: The review petitions were not maintainable on merits and stood dismissed.

Final Conclusion: The earlier direction for provisional release was maintained, the review challenge failed, and costs were imposed on the Customs Department for unnecessary action against the importers.

Ratio Decidendi: Products intended only for wellness and soothing purposes are not to be treated as medical devices requiring approval, and regulatory objections that can be cured post-release cannot, by themselves, defeat provisional release or justify review in the absence of a genuine error apparent on the face of the record.

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