Manufacture of Medical Devices for sale or for distribution

According to the guidance provided by the CDSCO on Medical device manufacturing and distribution:

Application for manufacture for sale or for distribution of Class A or Class B medical device.— (1) Any person who intends to manufacture a Class A or Class B medical device including in vitro diagnostic medical device shall make an application for grant of licence or loan licence to manufacture for sale or for distribution to the State Licensing Authority.

(2) The application under sub-rule (1) shall be made through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in Form MD-3 for licence or in Form MD-4 for loan licence accompanied with a fee, as specified in the Second Schedule along with respective documents as specified in Part II of the Fourth Schedule.

(3) The application made under sub-rule (1), shall, amongst others, be accompanied with an undertaking to the effect that the requirements of Quality Management System as specified in the Fifth Schedule have been complied with.

(4) The State Licensing Authority shall, after scrutiny of documents and on being satisfied that the requirements of these rules have been complied with, grant a licence to manufacture Class A medical devices in Form MD-5 or loan licence in Form MD-6, as the case may be, or if not satisfied, reject the application for reasons to be recorded in writing, within forty five days from the date, the application is made under sub-rule (1).

Provided that,—

(i) no audit of the manufacturing site shall be necessary prior to grant of licence or loan licence to manufacture for sale or for distribution of Class A medical device; and

(ii) the required audit of such manufacturing site by the registered Notified Body in the manner as specified in the Third Schedule shall be carried out within one hundred and twenty days from the date on which the licence was granted by the State Licencing Authority.

(5) Manufacturing site of the applicant, in respect of Class B device, shall conform to the requirements of Quality Management System as specified under the Fifth Schedule and applicable standards as specified under these rules and such conformance shall be verified through an audit by a Notified Body as referred under rule 13 before grant of licence.

(6) In case of application for grant of licence or loan licence to manufacture for sale or for distribution of Class B medical devices,—

(i) the audit of the manufacturing site shall be carried out within ninety days from the date of application by the registered Notified Body in the manner specified in the Third Schedule;

(ii) the Notified Body shall furnish its report to the State Licensing Authority within thirty days of the completion of audit;

(iii) the State Licensing Authority shall, after scrutiny of documents, audit report as referred to in clause 

(ii) and on being satisfied that the requirements of these rules have been complied with, grant a licence to manufacture Class B medical devices in Form MD-5 or loan licence in Form MD-6, as the case may be, or if not satisfied, reject the application for reasons to be recorded in writing, within a period of twenty days from the date of receipt of the report of audit by the Notified Body.

(7) If the application for grant of licence or loan licence to manufacture for sale or for distribution is rejected under sub-rule (4) or sub-rule (6), the aggrieved person may file an appeal before the State Government within forty five days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, be disposed of within a period of sixty days.

(8) Where the Central Licensing Authority or the State Licensing Authority has reason to believe or it has been alleged or suspected that the medical device does not conform to the standards of quality, or the provisions of the Fifth Schedule are not complied with, the State licensing Authority, in case of Class A or Class B medical device, or the Central Licensing Authority, in case of any Class of medical device, may direct a team of officers referred to in rule 23 to cause inspection of licenced manufacturing site.

21. Application for manufacturing Class C or Class D devices.— (1) An application shall be made to the Central Licensing Authority through an identified online portal of the Central Government for licence or loan licence to manufacture for sale or for distribution, as the case may be, of Class C or Class D medical device in Form MD-7 or Form MD-8, respectively.

(2) The application in Form MD-7 or Form MD-8 referred to in sub-rule (1) relating to Class C or Class D medical device, as the case may be, shall be accompanied with a fee as specified in the Second Schedule along with documents as specified in clause (ii) of Part II of the Fourth Schedule.

(3) The Central Licensing Authority may, wherever required, in case of Class C or Class D medical devices, use the services of any expert in the relevant field for scrutiny of application and other technical documents.

(4) The scrutiny referred to in sub-rule (3) shall be completed by the Central Licensing Authority within a period of forty five days from the date of online submission of application. 

(5) In case, where the documents are found to be complete and in order, the Central Licensing Authority shall cause an inspection of the manufacturing site carried out under rule 23 by a team of officers accompanied by such experts, as may be considered necessary.

(6) The Central Licensing Authority may, where required, avail the services of a Notified Body referred to in sub-rule 

(4) of rule 13 for inspecting the manufacturing site of Class C and Class D medical devices.

(7) In case, where the documents furnished with the application referred to in sub-rule (1) are not found to be complete and in order, the Central Licensing Authority shall reject the application and inform the applicant of the reasons for such rejection electronically:

Provided that where deficiencies that can be rectified, are pointed out by the Central Licensing Authority within the stipulated period, the period referred to in sub-rule (4) shall reckon from the date these deficiencies have been removed.

23. Inspection for grant of licence or loan licence for Class C or Class D medical device.— (1) Before grant of licence to manufacture for sale or for distribution in respect of Class C or D medical device, the manufacturing site shall be inspected within a period of sixty days from the date of application by a team comprising not less than two Medical Device Officers which may include any officer senior to the Medical Device Officer with or without an expert, or a Notified Body referred to in sub-rule (4) of rule 13: 

Provided that no inspection of a medical device manufacturing site for grant of loan licence to manufacture such medical device shall be required to be carried out if the manufacturing site is already licenced to manufacture such medical device for sale or for distribution.

Conditions for manufacturing licence or loan licence.— After grant of licence or loan licence in Form MD-5, Form MD-6, Form MD-9 or MD-10, as the case may be, the licence holder shall comply with the following conditions, namely:-

(i) licence shall be produced when requested by the Medical Device Officer or any other senior officer under the control of Central Licensing Authority or State Licensing Authority, as the case may be;

(ii) the licence holder shall inform the State Licensing Authority or the Central Licensing Authority, as the case may be, of the occurrence of any suspected unexpected serious adverse event and action taken thereon including any recall within fifteen days of such event coming to the notice of licence holder;