Centre to amend MDR to detail timelines related to medical devices manufacturing license
Posted on November 25, 2024 Updated on November 24, 2024
In order to better streamline the approval process for manufacturing license to the medical devices units, the Central government is looking at amending the relevant rules in the Medical Device Rules (MDR), 2017 to include various timelines related to grant of manufacturing license to the four classes of medical devices in the country.
The efforts are to add details to the existing rules, so that there would be more visibility for the industry related to certain procedures related to the approval of manufacturing licenses.
The Drugs Technical Advisory Board (DTAB), in its meeting held on August 14, 2024, had agreed to a proposed amendment in this regard, to include these timelines. This includes timelines related to approvals from the state regulator for the Class A and B and another part related to the central regulator’s approval for the Class C and D of the medical devices.
The license for manufacturing of Class A and Class B medical
devices is controlled by the State Licensing Authority (SLA) under Rule 20 of MDR, 2017. The timeline for scrutiny of applications, auditing of manufacturing sites with respect to compliance of Quality Management System (QMS) as per Fifth Schedule is prescribed under the Rule.
However, the specific timeline for audit to be carried out and compliance verification of non-conformance reported in previous inspection is not mentioned in the rule which resulted in delay in QMS inspection and compliance verification by the registered notified body in case of Class A and Class B medical devices. Therefore, the centre has proposed certain amendments to the Rule 20, of MDR, 2017.
As per the proposal, the State licensing authority, after scrutiny of documents to manufacture or loan licence Class B medical devices, take decision on either granting the licence or rejecting the application with reasons recorded in writing, within 45 days from the date of application. It also proposes to add a provision that if the deficiencies can be rectified, and pointed out by the State Licensing Authority within the stipulated period, the timeline would start from the date these deficiencies are removed. The State Licensing Authority shall also conduct an audit of the manufacturing site by a registered notified body.
Another amendment proposed is to the effect that the SLAs shall ensure that the audit of the site is carried by the registered notified body as per the regulations within a period of 45 days from the date of assignment of applications to notified body. In case the audit finds non-conformance of Quality Management System requirements, compliance verification shall be carried out within 20 days from the date of receipt of compliance report from manufacturer. The notified body shall furnish the report to the SLA within 15 days of completion of the audit.
For the Class C and D devices, while the timeline for scrutiny of applications, inspection of manufacturing sites with respect to compliance of QMS are prescribed under the Rule, specific timeline for inspection to be carried out is not prescribed.
In order to rectify this, the regulators has proposed amendment of the Sub-rule (1) of Rule 23 of MDR, 2017, to clarify that the license to manufacture Class C and D devices, manufacturing site shall be inspected within a period of 60 days after scrutiny application by a team comprising not less than two medical device officers. Earlier, the provision was to inspect the manufacturing site within a period of 60 days from the date of application.
The DTAB has deliberated the matter and agreed for a proposed amendment to include the various timeline for grant of manufacturing license, into the MDR, 2017.
It may be noted that the centre has been bringing in amendments and additions to the rules in order to improve the regulatory framework for medical devices after these devices were announced as drugs. The DTAB has also considered various other proposals related to amendment of MDR, 2017, and decisions to improve manpower management in the same meeting, in order to better regulate the sector.
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