CDSCO finalizes audit fee of Notified Bodies under Medical Devices Rules, 2017

Feb 26, 2018 | by Avantis RegTech Legal Research Team

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Central Drugs Standard Control Organization (CDSCO) vide notice dated February 21, 2018 has directed the notified bodies registered with CDSCO under provisions Medical Devices Rules, 2017 to carry out audit of manufacturing sites of as per Medical Devices Rules, 2017.

As per the provisions of Rule 16 of Medical Devices Rules, 2017, the fee chargeable by notified bodies, shall be as under:

·         Rs. 20, 000 per man-day for audit of manufacturing site including product assessment (on site/offsite).

·         Rs. 12,500 per man-day with package of Rs. 25000 requiring 2 man-days. In case, if more man-day required, it would be charged other than this fee.

·         Above fees are excluding travel cost which shall not normally be more thanRs. 12,000 per auditor/visit.

·         Man-day calculation criteria to be followed for assessment by NBs, which is based on number of products, Risk Class and effective number of employees, and prior experience

·         Annual Surveillance assessmentshall be 1/3 man-days of total initial assessment

·         Organization/Industry already certified to ISO 13485 from a NBand or CE mark certified for the same product is considered for reduction in man-days.

[File No:29/MlSC/3/2017-DC(288)]



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