(1) Small quantity of medical device, the import of which is not allowed, may be imported for personal use, on an application made by applicant in Form MD18 which shall be accompanied by documents confirming that the device is for legitimate personal use.
(2) On receipt of an application under sub-rule (1), the Central Licensing Authority shall, on being satisfied about the information and the documents enclosed with the application, grant permission in Form MD19.
(3) The medical device shall be imported subject to the following conditions, namely:-
(i) the medical device shall be deemed to be part of the baggage of a passenger or patient and be intended for, the exclusive use of the patient;
(ii) the medical device shall be declared as the personal property to the Customs Authorities if they so direct ;
(iii) the quantity to be imported is reasonable in the opinion of the Central Licensing Authority;
(iv) the medical device is prescribed by a registered medical practitioner; and
(v) the consignment of medical device shall be accompanied by an invoice or statement showing the name and address of the manufacturer and the name and quantity of medical device.
(4) Where the Central Licensing Authority is satisfied, it may, in exceptional and special circumstances, allow the import of larger quantity of medical devices for use by the patient.
Part VI Labelling of Medical Devices Labelling of medical devices.
39. The following particulars shall be printed in indelible ink on the label on the shelf pack of the medical device or on the outer cover of such medical device and on every outer covering in which the medical device is packed, namely:-
(a) proper name of medical device;
(b) the details necessary for the user to identify the device and its use;
(c) the name of the manufacturer and address of the manufacturing premises where the device has been manufactured;
(d) the correct statement of the net quantity in terms of weight, measure, volume, number of units, as the case may be, and the number of devices contained in the package, shall be expressed in metric system; and
(e) the date of manufacture and date of expiry; alternately the label shall bear the shelf life of the product:
Provided that in case of sterile devices, the date of sterilization may 23 be given as the date of the manufacture of the device:
Provided further that when the device is made up of materials such as stainless steel or titanium and supplied non-sterile, date of expiry may not be necessary;
Explanation: For the purpose of this rule, the date of expiry shall be in terms of month and year and it shall mean the medical device is recommended till the last day of the month. The date of expiry shall be preceded by the words ‘Expiry date’.
(f) to provide, wherever required, an indication that the device contains medicinal or biological substance;
(g) to provide, a distinctive batch number or lot number preceded by the word “Lot No.” or “Lot” or “Batch No.” or “B. No.”;
(h) to indicate, wherever required, any special storage or handling conditions applicable to the device;
(i) to indicate, if the device is supplied as a sterile product, its sterile state and the sterilisation method;
(j) to give, if considered relevant, warnings or precautions for the attention of the user of the medical device;
(k) to label the device, if the device is intended for single use;
(l) to overprint on the label of the container, the words “FOR CLINICAL INVESTIGATION ONLY”, if the device is intended for clinical investigation;
(m) to overprint on the label of the device, the words “Physician’s Sample- Not to be sold”, if a medical device is intended for distribution to the medical professional as a free sample;
(n) to provide, except for imported devices, the manufacturing licence number by preceding the words “Manufacturing Licence Number” or “Mfg. Lic. No.” or “M.
L”;
(o) devices or In-vitro diagnostics which are not sold to customer or patient directly and are sold for use by hospitals or diagnostic labs shall provide the information affixing additional label or sticker on outer shelf pack;
(p) to provide unique device identification of the medical device which shall contain device identifier and production identifier.
Explanation: for the purpose of this rule,-
(i) “device identifier” means global trade item number.
(ii) “production identifier” means serial number, lot or batch number, software as a medical device version, manufacturing and or expiration date.
(q) to provide on the label, in case of imported devices, with the approval of the Central Licensing Authority, the import licence number, name and address of the importer and address of the actual manufacturing premises, date of manufacture, (if not already printed at the time of import) may be stickered or overprinted on outer shelf pack:
24
Provided that the label may bear symbols recognised by the Bureau of Indian Standards or International Organisation for Standardization (ISO) in lieu of text and the device safety is not compromised by a lack of understanding on the part of the user in case the meaning of the symbol is not obvious to the device user.
Provided that all such medical devices on which the information cannot be printed legibly due to the small size constraints, shall include the information necessary for product identification and safety viz. information covered by clauses
(a), (b), (e), (g) and (k) above.
Exemption of certain labelling requirements for medical devices for export from India.
40. The labels on packages or container of devices for export shall be adopted to meet the specific requirements of law of the country to which the device is to be exported, but the following particulars shall appear in a conspicuous manner on the label of the inner most pack of the medical device in which the device is packed and every other outer covering in which the container is packed:-
(a) name of the Device;
(b) the distinctive batch number or lot number preceded by the word “Lot No.” or “Lot” or “Batch No.” or “B.No.”;
(c) date of expiry, if any;
(d) the name and address of the manufacturer and address of actual premises where the device has been manufactured;
(e) licence No. preceded by the letters “Licence No. or Lic. No.”.
(f) internationally recognised symbols in lieu of text, wherever required:
Provided that where a device is required by the consignee not to be labeled with the name and address of the manufacturer, the label on the packages or container shall bear a code number as approved by the Central Licensing Authority and the code number shall bear the name of the State or Union territory, in abbreviation, followed by the word “Device” and “manufacturing licence number”.
Provided further that where a device is required by the consignee not to be labeled with the code number also, the label on the packages or container shall bear a special code number, as requested by the consignee, and approved by the licensing authority.
Shelf life of the medical devices.
41. The shelf life of the medical devices shall not exceed sixty months from the date of manufacture:
Provided that this period may be extended by the Central Licensing Authority, in respect of any specified medical device, if satisfactory evidence is produced by the manufacturer to justify such extension:
Provided that the licensing authority shall not allow the import of any medical device, whose total shelf life claim is less than three months, having less than forty per cent. residual shelf-life period as on the date of import.
25
Provided further that the licensing authority shall not allow the import of any medical device, whose total shelf life claim is between three months and one year, having less than fifty per cent. residual shelf-life period as on the date of import.
Provided also that the licensing authority shall not allow the import of any medical device, whose total shelf life claim is more than one year, having less than sixty per cent. residual shelf-life period as on the date of import.
Labelling of medical device import or manufactured for purpose of clinical investigations, test, analysis, demonstration and training.
42. Any medical device imported or manufactured, for the purpose of clinical investigations, test, evaluation, demonstration and training, shall be kept in containers bearing labels, indicating name of the product or code number, batch or lot number, date of manufacture, use before date, storage conditions, name and address of the manufacturer, and the purpose for which it has been manufactured.
PART VII CLINICAL INVESTIGATION OF MEDICAL DEVICE AND CLINICAL PERFORMANCE EVALUATION OF NEW INVITRO DIAGNOSTIC MEDICAL DEVICE Conduct of clinical investigation.
43. No person or sponsor shall conduct any clinical investigation in respect of investigational medical device in human participants except in accordance with these rules and in accordance with the permission granted by the Central Licensing Authority.
Application of Rule 122DD of Drugs and Cosmetics Rules, 1945 with regard of Ethics Committee.