Annexure-A

LIST OF NOTIFIED MEDICAL DEVICES

1. Disposable Hypodermic Syringes

2. Disposable Hypodermic Needles

3. Disposable Perfusion Sets

4. In-vitro Diagnostic Devices for HIV, HbsAg and HCV

5. Cardiac Stents

6. Drug Eluting Stents

7. Catheters

8. Intra Ocular Lenses

9. I.V. Cannulae

10. Bone Cements

11. Heart Valves

12. Scalp Vein Set

13. Orthopaedic Implants

14. Internal Prosthetic Replacements

Annexure-B

109A. Labelling of medical devices.––Subject to the other provisions of these rules, the following particulars shall be printed in indelible ink on the label or sticker 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 the medical device;

(b) the details necessary for the user to identify the device and its use;

(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 the 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 the case of sterile devices the date of sterilisation may be given as date of the manufacture of the device:

Provided further that the device is made up of stable materials such as stainless steel or titanium, and supplied non-sterile, date of expiry may not be necessary;

(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 on the label, in case of imported devices, with the approval of the licensing authority mentioned in rule 21 (i.e. the Drugs Controller General of India), 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):

Provided that the label may bear symbols recognised by the Bureau of Indian Standards or International Organisation for Standardisation (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.’.

Annexure-C

109B. Exemption of certain labelling requirements for medical devices for export from India.–– The labels on packages or container of devices for export shall be adopted to meet specific requirements of the law of the country to which the device is to be exported, but the following particulars shall appear in conspicuous manner on the label of the shelf 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.”;

(d) the name and address of the manufacturer and address of actual premises where the device has been manufactured;

(e) the manufacturing Licence No. preceded by the letters “M.L. No” or “Manufacturing Licence No”;

(f) the 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 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 under rule 21 (i.e. the Drugs Controller General of India).