Discussion and overall conclusions The conclusions may include the following points:— (a) the safety and performance results and any other endpoints; (b) an assessment of risks and benefits; (c) a discussion of the clinical relevance and importance of the results in the light of other existing data; (d) any specific benefits or special precautions required for individual subjects or groups considered to be at risk; (e) any implications for the conduct of future clinical investigations; (f) any limitations of the clinical investigation. 9. Abbreviated terms and definitions A list of abbreviated terms and definitions of specialized or unusual terms should be provided. 10. List of appendices to the clinical investigation report (a) Protocols and amendments; (b) Specimen of Case Record Form; (c) Investigators' name(s) with contact addresses, phone, e-mail etc.; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 202 of 248 (d) Patient data listings (e) List of participants treated with investigational product; (e) Discontinued participants; (f) Protocol deviations; (g) CRFs of cases involving death and life threatening adverse event cases; (h) Publications from the investigation; (i) Important publications referenced in the clinical investigation; (j) Audit certificate, if available; (k)List of other parties involved (e.g. core labs, contract research organizations (CROs), experts, etc.); (1) List of monitors involved; (m) Investigator's certificate that he or she has read the report and that the report accurately describes the conduct and the results of the clinical investigation. EIGHTH SCHEDULE [Refer rule 90] EXEMPTIONS Sl. No. Class of medical devices Extent and conditions of exemption 1. Custom made device All provisions of Chapter IV and Chapter V of these rules, subject to the condition that the device is being specifically made in accordance with a duly qualified medical practitioner's written prescription under his responsibility, in accordance with specific design, characteristics and the same is intended for the sole use of a particular patient and the label contains the words 'custom made device'. Explanation : Mass produced devices, which only need adoption to meet the specific requirement of a medical practitioner or any other professional user, shall not be considered as custom made device. 2. Medicated dressings and bandages for first aid. The provisions of Chapter XI of these rules which require them to be covered by a sale licence, subject to condition that such products have been manufactured by licensed manufacturers. 3. Medical devices supplied by a All provisions of Chapter XI of these rules which require them to be covered by a sale Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 203 of 248 Sl. No. Class of medical devices Extent and conditions of exemption registered medical practitioner to his own patient or any medical device supplied by a registered medical practitioner at the request of another such practitioner if it is specially prepared with reference to the condition and for the use of an individual patient provided the registered medical practitioner is not (a) keeping an open shop or (b) selling across the counter, for distribution or sale of medical devices in India to a degree which render him liable to the provisions of Chapter IV of the Act and the rules made thereunder. licence subject to the following conditions:— (a) The medical devices shall be purchased only from a licensed manufacturer or licensed whole seller or retailer under these rules and records of such purchases showing the name and quantities of such medical devices, together with their batch numbers and names and addresses of the manufacturers shall be maintained. Such records shall be open to inspection by medical device officer appointed under this Act, who may, if necessary make enquiries about purchase of medical device and may also take samples for test. (b) Medical device shall be stored under proper storage conditions as specified in the label. (c) No medical device shall be sold or supplied or dispensed after the date of expiration recorded on its label or in violation of any statement or direction recorded on such label. 4. Medical devices supplied by a hospital or dispensary maintained or supported by Government or local body. All provisions of Chapter XI of these rules which requires them to be covered by a sale licence subject to the following conditions:— (a) The dispensing and supply of medical devices shall be carried out by or under the supervision of qualified person; (b) The premises where medical devices are supplied or stocked shall be open to inspection by a medical device officer appointed under this Act who can, if necessary, take samples for test. (c) The medical devices shall be stored under proper storage conditions. (d) The medical devices shall be purchased from a manufacturer or a whole seller or retailer licensed under these rules or received as transferred stocks from hospital stores for Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 204 of 248 distribution. Records of such purchases or receipts shall be maintained. (e) No medical device shall be sold or supplied or dispensed after the date of expiration recorded on its label or in violation of any statement or direction recorded on such label. 5. Mechanical contraceptives The provisions of Chapter XI of these rules which require them to be covered by a sale licence subject to the condition that the provisions of condition that no medical device shall be sold or supplied or dispensed after the date of expiration recorded on its label or in violation of any statement or direction recorded on such label. 6. Import of small quantity of medical devices donated to a charitable hospital for treatment of patients free of cost by that hospital. The provisions of Chapter V of these rules which require them to be covered by a licence for import provided that the Central Licensing Authority shall issue a No Objection Certificate for such purpose to the applicant. 54[7. All medical devices except those specified in the Annexure of Eighth Schedule. All the provisions of these rules subject to the condition that such medical devices shall be registered under CHAPTER IIIA of these rules: PROVIDED that such exemption shall cease after a period of thirty months for low risk - Class A and low moderate risk - Class B and after a period of forty-two mon ths for moderate high risk - Class C and high risk - Class D devices, respectively from the date of this notification. 55[8. Manufacturing of Class A non-sterile and non-measuring medical devices All provisions of Chapter IV, VII, VIII and XI of these rules, subject to the condition that the manufacturer shall make registration of such devices, under the provisions of Chapter IIIB of these rules. 9. Import of Class A non-sterile and nonmeasuring medical devices All provisions of Chapter V, VII, VIII and XI of these rules, subject to the condition that the importer shall make registration of such devices, under the provisions of Chapter IIIB of these rules.]