Documents Required For Medical Device Registration

Documents Required For Medical Device Registration

If you are willing to apply for an MD License in India then you must understand first which license you require. After understanding this you must collect all the documents required for medical device registration In India. For any registration of a medical device, you have to attach a few mandatory documents. With all the documents required for medical device registration, you should also have to attach a few more other documents that you are necessary after consulting with experts.

List Of Documents Required For Medical Device Registration

  • For medical device registration, you will need to upload the following documents on the CDSCO portal for registration.TR6 challan
  • Schedule D (I)
  • Declaration of conformity
  • Post-market surveillance (PMS) report 
  • Plan master file (PMF)
  • Free sale certificate 
  • Device master file (DMF)
  • ISO 13485 certificate
  • Power of attorney 
  • CE design certificate
  • Other regulatory certificates

TR6 challan

To address the payment of service tax, the TR6 challan is often utilized. To pay customs duty for the imported product, you can also use the TR6 challan.

Schedule D (I)

The manufacturer or agent needs to fill in the details and undertaking enclosed in Schedule D (I) through the application. The format should be appropriately filled in for application in Form 40. 

The confidentiality of such information should be maintained, and the applicant must deliver the content in an encrypted format. 

From the applicant willing to obtain a registration certificate, schedule D (I) seeks the following information.

  • Manufacturer and manufacturing facilities details.
  • Along with the existing certificates, details of the drug that is produced at the facility and undertaking to the declaration.

Declaration of conformity

It is a sort of legal document that states a product (from the electronic category) meets the regulations laid down by the statutory body, like CE, to assure the safety of the patient.

Post-Market Surveillance (PMS) Report

Post-market surveillance (PMS) report is a general assessment report that helps to depict a complaint trend for specific medical equipment by enclosing past data. To overcome loose ends of products, such a report can help the manufacturer that is likely to overshadow its functionality in one way or another. You should keep in mind that PMS is prepared against the products that already exist in the market that were already sold and serving clients from different regions.

Plant Master File 

The manufacturer drafted the Plant Master File, and details regarding quality management policies, site activities, quality control, and operation are enclosed by PMF. You should keep in mind that the Plant Master File must be site-specific, and it must compose existing information in the plant. PMF file must be confined around information regarding manufacturing practices activities related to GMP

Free Sale Certificate

In India, the State licensing authority issued the free sale certificate, and the process of exporting the drug to an overseas country has become easy with the Free sale certificate. For medical device manufacturers who wish to cater to the global market a free sale certificate is an essential certificate. A free sale certificate registration gives the note that the product is safe to use and in the country of export, it is already available.

Device Master File

A Device Master File contains the proprietary data regarding the material, component, or manufacturing process. The proprietary data isn’t in a prescribed format, as it could vary depending on the type of product or component. A typical Device Master File contains comparative analysis, test results, results of toxicity test and biocompatibility of the material and the component used in equipment.

ISO 13485 certificate

ISO 13485 serves the medical device industry, and it is a globally recognized certification. For quality management systems ISO 13485:2016 illustrates several requirements that can be used by a manufacturer engaged with the stages of the life cycle of the medical device. This standard also contains areas like design, development, manufacturing, storage, installation, servicing and decommissioning. To improve market presence the supplier of medical devices can voluntarily opt for this standard. The standard consistently exhibits the manufacturer’s ability to meet the regulatory requirements.

Power of Attorney

A power of is a legal document that is used to transfer the legal power from the property’s owner to another person like an agent. After the agent obtains the Power of Attorney, they have the legal authority for decision-making concerning the finances, principal’s property, or medical care, in a condition like when the property owner is not available for any reason, such as to sign the legal document, a Power of Attorney is used.

CE Design Certificate

The manufacturers whose product falls under the EC/EU directive category usually utilize the CE Design Certificate. The medical product requires a CE mark. However, it is necessary to conform to the design specification of such a directive.

Other regulatory certificate

Other product certificates are provided to the manufacturer by the local authorities, as well as the documents above. To speed up the registration process it could help the authority. 

What If You Missed Any Document During the Time Of Registration?

If you miss any of the mandatory documents, then your license application will be cancelled or suspended.

What Documents Are Required For Cdsco Registration?

Address proof document required for registration under CDSCO. Copy of CDSCO-approved BA/BE site registration. In case of import or manufacturer of Drug/blood product registration/test license registration manufacturing license or wholesale license.

What Is The Process Of Medical Device Approval?

To manage your device registration and interact with CDSCO on your behalf appoint an india authorized agent. Submit the device application and supporting documents to the CDSCO.

What Is The Cost Of Medical Device Registration In India?

The cost for one manufacturing site of class A or class B medical devices is 5000 INR. The price for each class A or class B medical device is 500 INR. The CDSCO defines the application fees for each category of medical devices.

How Do I Register A Class A Medical Device?

Non-notified devices must be registered with the CDSCO by anyone who desires to manufacture or import that Class A non-sterile and non-measuring medical device. To get their registration number they should apply at the online portal of the Ministry of Health and Family Welfare.

Does MDR require 13485?

Design, manufacturing, clinical evaluation, manufacturing, risk management, and post-marketing surveillance such various aspects covered by these requirements. MDR compliance gives a robust framework that indirectly ensures compliance when ISO 13485 is not mandatory for it. 

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