MD-12 Test Licence to Manufacture a Medical Device

What is Test License to Manufacture a Medical Device?

If you are manufacturing a small quantity of Class A or Class B or Class C or Class D of medical devices for the purpose of clinical investigations, test, evaluation, examination, demonstration or training, Test License is required for it.

Also to start with a fresh manufacturing of any medical device, a manufacturer must get a test license to manufacture the first lot of medical device for test.

How to get the Test License to manufacture a Medical Device?  

An Application made in FORM MD-12 to the Central Licensing Authority, CDSCO along with accompanied fee.

What are the documents required for filling an application?

  • A brief description of medical device including intended use, material of construction, design. 

  • List of equipment, instrument  

  • List of qualified personnel 

  • Copy of manufacturing license  

  • Approval letter authorizing to undertake research and development activities. 

How Authority accept or reject the application?

The Central Licensing Authority after enquiry, if requirements of these rules complied grant a license in Form MD-13 or either reject the application made under sub rule (1) if conditions are not compiled with. 

Period by which License granted remain in force. 

A license granted under sub rule (3) unless cancelled earlier, remain in force for period of three years from the date of its issuance.  

What are the conditions of Test License? 

The licensee uses the medical device exclusive for the purpose of clinical investigations, test, evaluation, examination, demonstration or training at the place specified in the license.  

The licensee allows any medical device officer to enter his premises with or without his notice and to satisfy himself that only clinical investigation, test, evaluation, examination, demonstration or training is conducted on such device.  

3 The licensee maintain record of all the quantity of medical device manufacture, tested and its disposition.  

Procedure to file Application in FORM MD-12  

The steps followed are:  

  •  The submitted applications are seen by the nodal officer. 

  •  The nodal officer assign applications to reviewing officer. 

  •  The nodal officer forwards the application to other reviewing officer if the previous reviewing officer is unavailable.  

  • Reviewing officer view/modify checklist and after reviewing generate note sheet. 

  •  The Reviewing officer forward the application for further processing directly to licensing authority. 

  • Licensing Authority review and generate note sheet and then approve application.  

  •  If Licensing Authority finds the application inappropriate can reject or raise Query. 

ELT Corporate and Medical Device Registration:

ELT Corporate is renowned for its services in all the fields of scientific licenses staring from Legal Metrology, BIS, Drugs and Cosmetics, Medical Devices, Food Safety, Environment safety to New Technology Patent. ELT Corporate has a team of Advocates, Engineers, M.Pharma, Chartered Accountants, Company Secretary. With such a unique combination of talent under a single roof, it has always been a hassle-free wonderful experience to the big corporates.

ELT Corporate is one of the best medical device consultant in India and always try to provide the best experience to the clients.

How we can help you with Medical Device Registration?

  • We help our clients to develop all the documents either, it may be Device Master File, Quality Manual or Management Responsibility.

  • We help our clients to maintain various records mandatory as per MDR 2017.

  • We even provide expert services on developing the Quality assurance labs.

  • We help our clients to communicate with government portals and ministry for getting the license done in minimum time.

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