Ministry of Health and Family Welfare proposes amendments to the Medical Devices Rules, 2017

Ministry of Health and Family Welfare proposes amendments to the Medical Devices Rules, 2017

May 5, 2018 Compliance Blog 0

In a recent notification dated April 27, 2018, the Ministry of Health and Family Welfare has invited suggestions and objections to the draft Medical Devices (Amendment) Rules, 2018 (“Draft Amendment Rules”).

The Draft Amendment Rules proposes to amend the Medical Device Rules, 2017 (“Principal Rules”).

The implications of the Draft Amendment Rules are as follows:

Principal Rules Draft Amendment Rules Implication
Fourth Schedule, Part II

 

(ii) Documents to be submitted with the application for grant of licence to manufacture or import Class B, Class C or Class D medical device,-

….

 

(h) In case of in vitro diagnostic medical devices, a copy of performance evaluation report issued by the central medical device testing laboratory or medical device testing laboratory registered under sub-rule (3) of rule 83.

 

 

 

Fourth Schedule, Part II

 

(ii) Documents to be submitted with the application for grant of licence to manufacture or import Class B, Class C or Class D medical device,-

….

 

(h) In case of in vitro diagnostic medical devices, performance evaluation report by the manufacturer shall be submitted by the applicant:

 

Provided that, when specifically required by State Licensing Authority for Class B or the Central License Authority for Class C and Class D in vitro diagnostic medical devices, as the case may be, applicant shall submit the report issued by the Central Medical Devices Testing Laboratory or a Medical Device Laboratory registered under rule 83 or by any Laboratory accredited by National Accreditation Board for Testing and Calibration Laboratories.

 

 

 

The Draft Amendment Rules has proposed amendments to the application process for grant of licence to manufacture or import in-vitro medical devices (Class B, Class C or Class D)

Presently, under the Principal Rules, domestic manufacturers are compulsorily required to submit performance evaluation report/s issued by the Central Medical Device Testing Laboratory or Medical Device Testing Laboratory Registered under the Rules.

The Draft Amendment Rules propose to amend this requirement by mandating applicants to submit the performance evaluation report by the manufacturer, instead.

A performance evaluation report by the Central Medical Devices Testing Laboratory or a registered Medical Device Laboratory will be required only if it is specifically required by the State Licensing Authority (for Class B) or the Central License Authority (for Class C and Class D).

 

 

 

Comments/ suggestions have been invited to the following address, within a period of thirty days from April 27,2018.

Under Secretary (Drugs)

Ministry of Health and Family Welfare,

Government of India,

Room No. 414 A, D Wing,

Nirman Bhavan,

New Delhi – 110011 or e-mailed at drugsdiv-mohfw@gov.in

Source: Ministry of Health and Family Welfare

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