(1) On receipt of the sealed package of medical device or portion thereof, from a Medical Device Officer or any other persons for test or evaluation, the Medical Device Testing Officer shall compare the seals on the packet or on portion thereof with the specimen impression received separately and shall note the condition of the seals on the packet or on portion thereof.
(2) After completion of test or evaluation, the Medical Device Testing Officer shall forthwith furnish a report to the Medical Device Officer in triplicate in Form MD28 of the result of the test or evaluation along with full protocols of the test or evaluation applied.
Application for test or evaluation of medical device.
62. For the purpose of these rules, an application from a purchaser for test or evaluation of a medical device or portion of medical device under section 26 of the Act shall be made in Form MD29 and the report of such test or evaluation of the medical device which is prepared on such application shall be supplied to the applicant in Form MD28.
Duties of medical device officer.
63. Subject to the instructions of the Central Licensing Authority or State Licensing Authority, as the case may be, it shall be duty of Medical Device Officer to,-
(i) inspect not less than once in a year all establishments licensed by the Central Licensing Authority as the case may be, for manufacturing of medical device 34 or State Licensing Authority for sale, distribution, exhibit or offer for sale of medical device, as the case may be, within the area assigned to him;
(ii) conform that the conditions of licence are being observed;
(iii) take samples of medical device manufactured or imported for sale, or stocked or exhibited for sale in respect of which, the Medical Device Officer has reason to suspect contravention of the provisions of the Act or these rules and send them for test or evaluation:
Provided that in case of large sized medical device, where in the opinion of the Medical Device Officer, drawing samples of such a device may not be physically practical, shall be inspected at the same place by the Medical Device Officer with or without expert and evaluated or tested by the Medical Device Testing Officer, for any suspect contravention, after approval of the Central Licensing Authority or State Licensing Authority, as the case may be;
(iv) maintain a record of all inspections undertaken, drawing of samples and seizure of stocks and action taken by Medical Device Officer in exercise and performance of duties and to furnish copies of such record to the Central Licensing Authority or State Licensing Authority, as the case may be;
(v) make such enquiries and inspections as may be necessary to detect the manufacture or sale of medical device in contravention of any provision of the Act and these rules;
(vi) investigate any complaint relating to medical device in writing which may be made to the Medical Device Officer;
(vii) institute prosecution in relation to contravention of the provisions of the Act and these rules;
(viii) review technical dossier of medical device furnished with the application under these rules or any other duties assigned by the Central Licensing Authority or State Licensing Authority, as the case may be, related to these rules.
Prohibition of disclosure of information.
64. Except for the purpose of official business or when required by a Court, a Medical Device Officer shall not, without the sanction in writing of his official superior, disclose to any person any information acquired while exercising such official duties.
Form of order not to dispose of stock.
65. An order in writing by a Medical Device Officer under clause (c) of sub-section
(1) of section 22 of the Act requiring a person not to dispose of any stock in his possession shall be in Form MD30.
Prohibition of sale. 66. No person in possession of a medical device in respect of which a Medical Device Officer has made an order under clause (c) of sub-section (1) of section 22 of the Act shall, in contravention of that order, sell or otherwise dispose of any stock of such medical device.
35 Form of receipt for seized medical devices, record, register, documents or any other material objects.
67. A receipt by a Medical Device Officer for the stock of any medical device or for any record, register, document or any other material object seized under clause
(c) or clause (cc) of sub-section (1) of section 22 of the Act shall be in Form MD31.
Manner of certifying copies of seized documents.
68. The Medical Device Officer shall return the document, seized under section 22 of the Act, within a period of twenty days from the date of such seizure, to the person from whom they were recovered or produced, after copies thereof or extracts therefrom have been signed by the concerned Medical Device Officer and the person from whom they were recovered or produced.
Form of intimation of purpose of taking samples.
69. When a Medical Device Officer takes a sample of a medical device other than medical device specified in proviso to sub-rule (iii) of rule 63 for the purpose of test or evaluation, Medical Device Officer shall inform such purpose in writing in Form MD32 to the person from whom it takes and shall tender the fair price thereof under a written acknowledgement.
Form of receipt for samples of medical devices where fair price tendered is refused.
70. Where the fair price tendered under sub-section (1) of section 23 of the Act for sample of medical device or portion thereof taken for the purposes of test or evaluation has been refused by the person from whom such sample has been taken, the Medical Device Officer shall tender a receipt thereof to such person in Form MD33.
Procedure for dispatch of sample to medical device testing officer.