Second Amendment in Medical Device Rules, 2017

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-21082026-275637 EXTRAORDINARY PART II—Section 3—Sub-section (i) PUBLISHED BY AUTHORITY No. 677] NEW DELHI, WEDNESDAY, AUGUST 19, 2026/SHRAVAN 28, 1948 4 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 14th August, 2026 G.S.R. 743(E).— Whereas a draft of certain rules further to amend Medical Device Rules, 2017, were published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide number G.S.R. 270(E), dated the 10th April, 2026 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), inviting objections and suggestions from all person likely to be affected thereby before the expiry of a period of thirty days from the date which on the copies of the Official Gazette containing the said notification was published were made available to public; And whereas, copies of the said Official Gazette were made available to the public on 10th April, 2026; And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with Drugs Technical Advisory Board, hereby makes the following rules further to amend the Medical Devices Rules, 2017, namely:— 1. (i) These rules may be called the Medical Devices (Second Amendment) Rules, 2026. (ii) These rules unless specified otherwise, come into force on the date of their final publication in the Official Gazette. 2. In the said rules, in clause (j) of rule 3, the word “of a licencee” shall be omitted. 3. In the said rules, after the clause (y)of rule 3, the following clause shall be inserted: (ya) "Certificate of Registration" means a registration certificate granted by the State Licensing Authority or the Central Licensing Authority in Form MD-2, Form MD-40 and Form MD-42 as the case may be." 4. In the said rules, after clause (o) of Rule 44, the following clause shall be inserted. (p) In case of medical device manufacturer who outsourced the sterilization activity at the site of another facility having valid license to carry out sterilization process of medical devices, the license number of the sterilization site should be mentioned on label of the device. The sterilization site license number by preceding the words "Sterilization sites Manufacturing License Number" or "Ster. Mfg. Lic. No.” or “S.M. L." 5. In the said rules, in the clause (o) of Rule 44, after the words “and (m)”, shall be substituted by the words, "(m) and (p)." Provided, the compliance with clause (p) shall be mandatory with effect from six months from the date of this notification. 6. In the Medical Devices Rules, 2017, (hereinafter referred to as the said rules), after Eighth Schedule, the Ninth Schedule shall be inserted namely: - Ninth Schedule Fee for test or evaluation [See rules 19, 69] +--------+-------------------------------------------------------------+-----------------------------+ | Sr. No. | Type of Test/Evaluation | Cost of Test/ | | | | Evaluation in | | | | rupees (INR) | +--------+-------------------------------------------------------------+-----------------------------+ | (1) | (2) | (3) | +========+=============================================================+=============================+ | 1. | Implantation test | 5000 | +--------+-------------------------------------------------------------+-----------------------------+ | 2. | Sterility test | 2000 | +--------+-------------------------------------------------------------+-----------------------------+ | 3. | Surgical Dressings | 1000 | +--------+-------------------------------------------------------------+-----------------------------+ | 4. | Syringes & needles | 1000 | +--------+-------------------------------------------------------------+-----------------------------+ | 5. | Physical test / Physiochemical test for perfusion sets etc., | 2000 | +--------+-------------------------------------------------------------+-----------------------------+ | 6. | Surgical Sutures | 3000 | +--------+-------------------------------------------------------------+-----------------------------+ | 7. | Optical Rotation, Specific Gravity, Refractive Index, weight | 250 each | | | per ml, Fluorescence etc. | | +--------+-------------------------------------------------------------+-----------------------------+ | 8. | Absorbency, Weight per unit area (Surgical), Foreign matter, | 150 each | | | Extractive value, Threads count, Length & Width (Surgical), | | | | Surface active substances, Acidity or alkalinity, Neps, | | | | Setting time etc. | | +--------+-------------------------------------------------------------+-----------------------------+ | 9. | Condoms | 2500 | +--------+-------------------------------------------------------------+-----------------------------+ | 10. | Intrauterine Devices | 2500 | +--------+-------------------------------------------------------------+-----------------------------+ | 11. | Bacterial endotoxin test | ---- | | | a. Qualitative | 3000 | | | b. Quantitative | 4500 | +--------+-------------------------------------------------------------+-----------------------------+ Note: - 1. For test/evaluations not specified in the above table, charges shall be determined by the Director or Medical Device Testing Officer of the Laboratory/Institute as the case may be. 2. The prescribed cost of the test/analysis shall automatically increase by 5% annually. 7. In the said rules, in Chapter III, in rule 19, after sub-rule (2), the following sub-rule shall be inserted namely: - "(3) The fees for test or evaluation shall be those specified in ninth Schedule." 8. In the said rules, in Chapter IX, in rule 69, after the words in “Form MD-33", the words “accompanied with a fee specified in the Ninth Schedule" shall be inserted. [F. No. X.11035/112/2024-DR] HARSH MANGLA, Jt. Secy. Note: The Medical Devices Rules, 2017 was published in the Official Gazette vide notification number 78 (E), dated the 31st January, 2017 and last amended vide notification number G.S.R. 165(E), dated 2nd March, 2026.