Executive Summary:
This notification announces the Medical Devices Fifth Amendment Rules, 2019, which further amend the Medical Devices Rules, 2017. The amendment exempts State and Central Government testing laboratories from mandatory accreditation by the National Accreditation Board for Testing and Calibration Laboratories (NABL) for two years from the date the amendment comes into force. These rules were published by the Ministry of Health and Family Welfare on October 16, 2019, and are effective from the date of publication in the Official Gazette.
Key Points / Main Content:
* **Amendment Title and Authority**:
* These rules are called the Medical Devices Fifth Amendment Rules, 2019.
* The rules are made in exercise of powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940.
* **Effective Date**:
* The rules come into force on the date of their publication in the Official Gazette.
* **Amendment to Rule 19 of Medical Devices Rules, 2017**:
* A proviso is inserted after the existing proviso in rule 19.
* **Exemption from NABL Accreditation**:
* Testing laboratories of State Governments and the Central Government are exempted from accreditation by the National Accreditation Board for Testing and Calibration Laboratories (NABL).
* **Exemption Period**:
* The exemption period is two years from the date of coming into force of the Medical Devices Fifth Amendment Rules, 2019.
Impact Analysis
**State and Central Government Testing Laboratories:**
* Impact: Exempted from the requirement of accreditation by NABL for two years.
* Action Required: Continue operations without NABL accreditation for the specified period while adhering to other applicable standards and regulations.
**National Accreditation Board for Testing and Calibration Laboratories (NABL):**
* Impact: Reduced demand for accreditation from State and Central Government testing laboratories for two years.
* Action Required: Acknowledge the exemption and adjust accreditation processes accordingly.
**Medical Device Manufacturers:**
* Impact: May utilize testing services from State and Central Government laboratories without NABL accreditation for a two-year period, potentially reducing testing costs or providing more options.
* Action Required: Be aware of the change in accreditation requirements for State and Central Government laboratories and consider the implications for their testing strategies.
**Central Government (Ministry of Health and Family Welfare):**
* Impact: Implementation and oversight of the amended rules.
* Action Required: Ensure effective communication and enforcement of the new rules, and monitor their impact on the quality and safety of medical devices.
Key Entities Referenced
Medical Device Rules, 2017: A set of rules pertaining to medical devices, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: An Act of the Indian Parliament that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
Medical Devices Fifth Amendment Rules, 2019: The title of the amendment rules introduced by this notification.
Central Government: The Union Government of India.
Drugs Technical Advisory Board: A statutory body constituted by the Government of India under the Drugs and Cosmetics Act, 1940 to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act.
National Accreditation Board for Testing and Calibration Laboratories: An accreditation body for testing and calibration laboratories in India.
Dr. Mandeep K. Bhandari: Joint Secretary in the Government of India, as indicated by the signature on the notification.
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 16th October, 2019
G.S.R.787(E).— Whereas a draft of certain rules further to amend the Medical Device 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. 87 (E), dated the 4th February, 2019 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 said Official Gazette were made available to the public on 5th February, 2019;
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 and 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:―
1. (1) These rules may be called the Medical Devices (Fifth Amendment) Rules, 2019.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Medical Devices Rules, 2017, in rule 19, after the proviso, the following proviso shall be inserted,
namely:―
“Provided further that the testing laboratories of State Governments and Central Government shall be
exempted from the requirement of the accreditation by the National Accreditation Board for Testing and
Calibration Laboratories for a period of two years from the date of coming into force of the Medical Devices
(Fifth Amendment) Rules, 2019.”.
[F.No.X.11014/1/2019-DR]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
Note:- The Medical Devices Rules, 2017 was published in the Official Gazette vide notification number G.S.R. 78(E),
dated the 31st January, 2017 and last amended vide notification number G.S.R. 652(E), dated the 13th September, 2019.
Uploaded by Dte. of Printing at Government of India Press, Ring Road,Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.