Last Updated on December 31, 2023 by The Health Master
The Union health ministry has issued draft notification vide No. GSR 98 (E) dt 05-02-2021 on Medical Devices Amendment Rules, 2021 to include American Standard Test Method (ASTM) in product standards for medical devices to enhance competitiveness of indigenous medical devices globally.
To read or download the draft notification vide No. GSR 98 (E) dt 05-02-2021, click here
As per the draft rules, these rules may be called the Medical Devices (Amendment) Rules, 2021. These rules shall, unless specified otherwise, come into force on the date of their final publication in the Official Gazette.
In the Medical Devices Rules (MDR) 2017, in Rule 7, in Sub-Rule (2), after the words, letters and bracket “the International Electro Technical Commission (IEC)” the words, letters and bracket “or American Standard Test Method (ASTM)” shall be inserted.
Rule 7 of the MDR -2017 provides product standards for medical devices. The MDR- 2017 was published in the Official Gazette vide notification number G.S.R. 78 (E), dated the January 31, 2017.
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The following draft of certain rules to amend MDR- 2017, is done in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics (D&C) Act, 1940 (23 of 1940) and after consultation with the Drugs Technical Advisory Board (DTAB) is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from the date on which copies of the Gazette of India containing these draft rules are made available to public.
The period specified above will be considered by the Central Government; Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs Regulation), Union Health Ministry, Government of India, Room Number 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in.
Drugs Technical Advisory Board (DTAB) after detailed deliberation agreed to the proposal and recommended for necessary amendment in the MDR- 2017 in this regard.
Stakeholders and experts have been recommending an urgent need for the government to align the regulatory regime as per existing global standards to enable Indian medical device manufacturers to enhance their competitiveness and scale towards becoming export friendly.
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For more details on licensing process of Medical devices, click here
For notifications of Medical Devices, click here
It has been recommended that developed countries have their own certification requirements. Therefore, Indian medical device manufacturers will need to meet the requirements of countries where they export.
As per Rule 7 of MDR-2017, the medical device shall conform to the standards laid down by the Bureau of Indian Standards (BIS) established under Section 3 of BIS Act, 1985 (63 of 1985) or as may be notified by the Union health ministry, from time to time.
Where no relevant standard of any medical device has been laid down under Sub-Rule (1), such device shall conform to the standard laid down by the International Organisation for Standardization (ISO) or International Electro Technical Commission (IEC) or by any other pharmacopoeial standards.
In case of the standards which have not been specified under Sub-Rule (1) and Sub-Rule (2), the device shall conform to the validated manufacturer’s standards. Since the ASTM is accepted globally, it was proposed to include the ASTM in the Sub-Rule (2) of the Rule 70 of MDR-2017.
DTAB was apprised that the Union health ministry has notified the MDR- 2017 on January 31, 2017 under the provisions of the Drugs and Cosmetics (D&C) Act, 1940.
New MDR -2017 are effective from January 1, 2018 to regulate the clinical investigation, manufacture, import, sale and distribution of the medical devices in the country.
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