New Delhi, the 15th January, 2019 G.S.R. 30(E).—Whereas a draft of certain rules further to amend the Medical Devices Rules, 2017, was
published as required by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 848 (E), dated the 7 th September, 2018, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas copies of the Official Gazette were made available to the public on 14 th September, 2018; And whereas objections and suggestions received from the public on the said rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Medical Devices Rules, 2017, namely:-
Paragraph 1
1. (1) These rules may be called the Medical Devices (Amendment) Rules, 2019. (2) They shall come into force on the date of their publication in the Official Gazette.
Paragraph 2
2. In the Medical Devices Rules, 2017 (hereinafter to be referred as said rules), in rule 3, in clause (v), after the words “instructions for use”, the words “or electronic instructions for use” shall be inserted.
Paragraph 3
3. In the said rules, in rule 59, in sub-rule (3), in clause (iii), after the words “instructions for use”, the words “or electronic instructions for use” shall be inserted.
Paragraph 4
4. In the said rules, in Fourth Schedule, ― (A) in Part II, under the heading “Document to be submitted with the application for grant of Import Licence or licence to manufacture for sale or for distribution of a Class A medical device” in paragraph (a), in the Table, against serial number 4, for the letters “IFU” occurring in both columns (2) and (3), the words “instructions for use or electronic instructions for use” shall be substituted; (B) in Part III, in Appendix II,― (i) in para 2.1, in clause (a) for the words “instructions for use”, the words “instructions for use or electronic Instructions for use” shall be substituted; (ii) in para 3.0, for clause (b) the following clause shall be substituted, namely: ― “(b) Instructions for use or electronic instructions for use (Prescriber’s manual);”; 4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] (C) in Part IV,― (i) in paragraph (a), for serial number 8 and the entries relating thereto, the following serial number and entries shall be substituted, namely: ― “8. Proposed instructions for use or electronic instructions for use and labels.”; (ii) in paragraph (b), for serial number 5 and the entries relating thereto, the following serial number and entries shall be substituted, namely:― “5. Proposed instructions for use or electronic instructions for use and labels.”.
Paragraph 5
5. In the Seventh Schedule, ― (a) in paragraph 1, in sub-paragraph (1), in clause (v),― (i) for the words “Instructions for use”, the words “instructions for use or electronic instructions for use” shall be shall be substituted; (ii) in the proviso, for the words “Instructions for Use”, the words “instructions for use or electronic instructions for use” shall be shall be substituted; (b) in Table 3, for serial number 11 and the entries relating thereto,, the following serial number and entries shall be substituted, namely: ― “11. Proposed instructions for use or electronic instructions for use and labels.”.
[F.No.X.11014/20/2018-DR] Dr. MANDEEP K. BHANDARI, Jt. Secy. Note : The principal rules were published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide notification number G.S.R. 78(E), dated the 31 st January, 2017 and last amended vide notification number G.S.R. 729(E), dated the 1 st August, 2018.