Sun, June 28, 2026
New Delhi: The Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules, 2017, aimed at speeding up the approval process for manufacturing licences while making it easier for businesses to operate in India's growing medical devices sector.
The proposed changes, announced on Sunday, seek to simplify regulatory procedures without compromising the quality, safety and performance standards of medical devices.
The ministry has issued a draft notification in the Official Gazette and invited comments from stakeholders before the amendments are finalised.
Under the current regulatory framework, medical devices are classified into four risk-based categories—Class A, Class B, Class C and Class D—with Class D covering the highest-risk products.
One of the key proposals is to reduce the time taken to issue manufacturing licences. For Class B devices, which include products such as blood pressure monitors, pulse oximeters and hypodermic needles, the approval timeline is proposed to be reduced from 140 days to 115 days.
For higher-risk Class C and Class D devices, including cardiac stents, hip and knee implants, and other orthopaedic implants, the proposed approval period has been shortened from 105 days to 90 days.
The draft amendments also introduce clearly defined timelines for every stage of the licensing process, including application scrutiny, audits by notified bodies, compliance verification and licence issuance. According to the ministry, these measures will make the regulatory system more transparent, predictable and efficient.
The government believes the proposed reforms will strengthen India's medical devices ecosystem by enabling manufacturers to bring quality-assured products to the market more quickly while maintaining stringent regulatory standards.
The ministry said the changes are expected to benefit both manufacturers and patients by ensuring faster availability of safe and reliable medical devices across the country.
The draft notification has been published in the Official Gazette and is also available on the website of the Central Drugs Standard Control Organisation. Stakeholders have been invited to submit their suggestions and feedback within the prescribed period before the rules are finalised.
With inputs from IANS
| 14-09-2018 | ||||||
| Sl No. | Parameters | Actual Data(µg/m3) | Standard Limit(µg/m3) |
|---|---|---|---|
| 1 | PM 10 | 64 | 100 |
| 2 | PM 2.5 | 33 | 60 |
| 3 | SO2 | 55.3 | 80 |
| 4 | NO2 | 58.2 | 80 |
| 14-09-2018 | ||||||
| Station | Temperature(degree centigrade) | Rainfall(mm) | Relative humidity(%) | |||
|---|---|---|---|---|---|---|
| Max | Min | Past 24 hrs. | Since 1st March, 2018 | Max | Min | |
| Ranchi | 31.0 | 22.5 | 000.0 | 1010.1 | 95 | 66 |
| Jamshedpur | 34.1 | 26.2 | 000.0 | 1252.8 | 87 | 58 |
| Bokaro | 33.5 | 24.6 | 015.2 | 824.0 | 92 | 79 |
| Daltonganj | 32.6 | 24.9 | 004.2 | 960.9 | 95 | 67 |
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