19K. Registration number for import.― The registration number for import of a class A non-sterile and non-measuring medical device shall be generated after furnishing of the information in accordance with rule Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. 19J on the Online System for Medical Devices established for this purpose. 19L. Maintenance of records.― (1) The manufacturer or, as the case may be, importer shall maintain the records relating to manufacturing or importing along with its sales or distribution. (2) The manufacturer or, as the case may be, importer shall produce the records, labels, instructions for use, on request by Licensing Authorities. (3) The Licensing Authorities may verify the records and documents referred to in sub-rule (2) at any point of time and investigate quality or safety related failures or complaints.
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