This is to inform you that in a Gazette Notification dated 5th February, 2021 the Ministry of Health and Family Welfare (“Ministry”) has issued a draft of the Medical Devices (……Amendment) Rules, 2021 (“Draft Rules”) in order to further amend the Medical Device Rules, 2017 (“Principal Rules”).
Comments are invited from the public within 22nd March, 2021 after which the Draft Rules will be taken into consideration.
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in.
The Draft Rules, unless specified otherwise, will come into force on the date of their final publication in the Official Gazette.
For a detailed read of the proposed amendment, please refer to the table below:
| Principal Rules | Draft Rules | Implication |
| Rule 7: Product standards for medical device.—
(1) The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.
(2) 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 Standardisation (ISO) or the International Electro Technical Commission (IEC), or by any other pharmacopoeial standards.
(3) 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. |
Rule 7: Product standards for medical device.—
(1) The medical device shall conform to the standards laid down by the Bureau of Indian Standards established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.
(2) 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 Standardisation (ISO) or the International Electro Technical Commission (IEC), or American Standard Test Method (ASTM) or by any other pharmacopoeial standards.
(3) 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. |
The proposed amendment is regarding product standards for medical device.
Where no relevant standard for any medical device has been laid down, such device will have to conform to the standard laid down either by- i. International Organisation for Standardisation (ISO)
ii. International Electro Technical Commission (IEC)
iii. American Standard Test Method (ASTM)
or by any other pharmacopoeial standards
The ASTM is proposed to be inserted. |
Source: Ministry of Health And Family Welfare
