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Test License for Manufacturers

MD-12 test license to manufacture medical devices

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, tests, evaluations, examinations, demonstrations,s or training, a Test License is required for it.

Also to begin with the new manufacturing of any medical device, a manufacturer must first obtain a trial license to manufacture medical devices for testing.

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 the accompanying fee.

What are the documents required for filling out an application?

A brief description of the medical device including intended use, the 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 does Authority accept or reject the application?

The Central Licensing Authority after inquiry, 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 remains in force. 

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

What are the conditions of the Test License? 

1 The licensee uses the medical device exclusively for the purpose of clinical investigations, tests, evaluations, examinations, demonstration, or training at the place specified in the license.  

2 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 maintains a record of all the quantity of medical devices manufactured, tested, and their disposition.  

Procedure for filing application in Form MD-12

The steps followed are:

The submitted applications are looked after by the Nodal Officer.

The nodal officer hands over the application to the review officer.

If the previous Review Officer is not available, the Nodal Officer forwards the application to other Review Officers.

View/Revise Review Officer Checklist and make a note sheet after reviewing.

The Reviewing Officer forwards the application directly to the Licensing Authority for further processing.

Licensing officers review and prepare a note sheet and then approve an application.

If the Licensing Authority feels that the application is unsuitable, it may reject or extend the query.

ELT Corporate And Medical Device Registration:

ELT is renowned for its services in all areas of scientific licensing from Corporate Legal Metrology, BIS, Drugs & Cosmetics, Medical Devices, Food Safety, and Environment Safety to New Technology Patents. ELT Corporate has a team of Advocates, Engineers, M.Pharma, Chartered Accountants, and a Company Secretary. With such a unique combination of talent under one roof, it has always been a hassle-free wonderful experience for large corporates.

ELT Corporate is one of the best Medical Device Consultants in India and has always endeavored to provide the best experience to its clients.

How we can help you with Medical Device Registration?

We help our customers develop all documentation, whether it's a device master file, a quality manual, or management accountability.

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

We also provide expert services in developing quality assurance laboratories.

We help our clients to communicate with the government portals and ministry to get the license in the shortest possible time.

 

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