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How To Apply Manufacturing License For Medical Device In India?

If you are manufacturer or distributor, looking for manufacturing license for your Medical Device, this guide will help you to simply understand the documents and procedure of obtaining manufacturing license for medical device in India. Manufacturing license is issued by the licensing authority of India. Classification of medical device determines which licensing authority responsible for issuing manufacturing license. State licensing authority is responsible for grant of manufacturing license for class A and B medical device. Central licensing authority is responsible for issuing manufacturing license for class C and D medical device based on the risk it possesses. This guide will help you to figure out your queries for obtaining manufacturing license for medical device in India.

Who Can Apply For Manufacturing License For Medical Device?

Below are some individual who can apply for manufacturing license for medical device in India:

Manufacturer: who is responsible for production and manufacturing of medical device can apply for manufacturing license.

Importer: Person who is looking to Import medical device in India can apply for manufacturing license.

Distributor or Authorized Person: Person who is authorized from manufacturer can apply for license.

What Is Medical Device? How Many Classes Of Medical Device Are there?

Medical device is any instrument, equipment, implant, or machine that is used in diagnosis, treatment, and mitigation of disease in humans. Medical device are classified into four types based on the risk it possesses:

Class A: Low risk medical device (stethoscope and bandages)

Class B: Intermediate risk (syringe and glucose meter)

 Class C: Moderate high risk ( catheter and implants)

Class D: Very high risk (heart valves)

Documents Required For Obtaining Manufacturing License For Medical Device In India

For the grant of manufacturing license for your medical device, following are some key documents required as per CDSCO guidelines:

Application Form: Form MD-3 is filled for class A and B medical device, form MD-7 for class C and D medical devices.

Plant Master File: Plant master file having information about the manufacturing site, layout of facility, and equipment used.

Device Master File: Detail description of medical device and risk possibilities along with the specifications and design.

Quality Management System: QMS certificate issued under ISO 13485 certification demonstrating high performance quality standard of medical device in compliance with regulatory framework.

Technical Documents: Most important documents including product specifications, clinical report and risk management plan of medical device.

Stability Data: Stability data demonstrating the shelf life of medical device.

Deceleration or Understanding: Understanding from manufacturer, ensuring compliance of medical device with regulatory standards.

Labelling and Packaging: Details of labelling for medical device is required as per Medical Device Rules, 2017.

Procedure To Obtain Manufacturing License For Medical Device

Following are the main steps for the grant of manufacturing license:

Visit Sugam Portal: Register on the CDSCO/sugam portal by creating an account.

Application Submission: Select the Form applicable as per your medical device registration. Fill the form details carefully and submit on the portal.

Fee Payment: Pay the applicable money as per the Medical Device Rules, 2017.

Audit Inspection: Specific regulatory authority will conduct the inspection of product manufacturing site, to ensure the compliance of medical device as per the regulatory standards.

License Issuance: After the successful evaluation of manufacturing site along with your application form documents, Licensing authority will grant the manufacturing license.

How Medwisdom Lifescience Can Assist You With Obtaining Manufacturing License?

Medwisdom offers expert assistance in medical device registration and license, we have secured over 2500 medical device registration so far, we take pride in our exclusive achievement for grant of 500 plus manufacturing license across all classes of medical device (A to D). Our expertise ensure timely registration and cost effective solutions for obtaining manufacturing license.

FAQS

Who Needs Manufacturing License For Medical Device In India?

Any company or individual planning to manufacture medical device for the purpose of sell or marketing, must obtain the manufacturing license for medical device under the Medical Device Rules, 2017.

Who Issue Manufacturing License For Medical Device?

State Licensing Authority is responsible for issuing manufacturing license for class A and class B medical device. Central Licensing Authority

What Is The Validity of Manufacturing License For Medical Device?

Validity of manufacturing license is five years from the date of issue.

What Is The Timeline For Obtaining Manufacturing License?

The approximate time for obtaining manufacturing license for medical device takes 5-6 months, based on the completeness of your application and the response from the regulatory authority.

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What is Drug Regulatory Affairs & Why It is Important?

Regulatory Affairs is the crucial department for Pharmaceutical, Medical Device, Cosmetics, Herbal, and Food Industry that must comply with the global regulatory framework to ensure safety for human use. Regulatory Affairs helps industries and companies at every stage of product life cycle and to get ready with legal and technical documents and dossier in order to get market approval and registration of products in both domestic and International markets. This is a small guide to drug regulatory affairs about the importance, goal, and functions of pharmaceutical regulatory affairs in India and global market.

What Is Drug Regulatory Affairs?

Drug regulatory affairs (DRA) is a discipline in pharmaceutical sciences that ensures quality, safety, and efficacy of drug products. Drug regulatory affairs in India involves the preparation and submission of documents for drug product approval and marketing for commercial purposes. DRA professionals act as the bridge between the pharmaceutical industry and the regulatory authorities like Central Drug Standard Control Organization (CDSCO) for India, United States Food and Drug Administration (US FDA) for US, and European Medicine Agency (EMA) for Europe. 

Primary Goal of Drug Regulatory Affairs

Drug regulatory affairs primary goal is to ensure that drug product meets regulatory standard set by the country specific regulatory authorities for marketing of medicine. Regulatory authorities are responsible for safeguarding the public health by setting the regulatory framework. Therefore, before marketing of drug product, it must follow the regulatory standard, ensuring the safety, quality, and efficacy of drug product in order to 

Importance Of Drug Regulatory Affairs In Pharmaceutical Industry?

Pharmaceutical regulatory affairs plays an important role in ensuring regulatory compliance of drug products with the regulatory framework of specific countries. Pharmaceutical regulatory affairs  is essential for safeguarding public health by making assurance that only safe and effective drugs reaches to consumers. DRA fosters innovation by guiding companies to overcome hurdles of complex regulatory pathway of product approval, ensuring timely market access.

What Are The Benefits Of Drug Regulatory Affairs?

Pharmaceutical regulatory affairs have several benefits, some of the common are listed below:

Drug safety and efficacy assurance 

Regulatory compliance of drug products with the required standard 

Enhances product approval and market acceptance 

Smooth market access on time

Monitor safety of drug through post-marketing surveillance (Pharmacovigilance)

Ensures high quality and safety drug available to consumers, promoting public health 

Establish consumer trust through maintaining  transparency and good regulatory practice 

 What Is The Role of Drug Regulatory Affairs In Drug Development?

Role of drug regulatory affairs in drug development is crucial as it is integral to every phase of drug development, ensuring smooth changes from laboratory to marketing and commercialization. Some key points of pharmaceutical regulatory affairs roles are as follows:

Clinical study design and safety monitoring of drugs

Regulatory submission of application (IND, NDA, AND ANDA) for product approval and marketing venture 

Labelling and packaging of drug products 

Product lifecycle management from initial registration to renewal of product 

Major Functions of Drug Regulatory Affairs?

Below are the major functions of pharmaceutical regulatory affairs in India:

Dossier preparation and submission to get the registration of products 

Regulatory compliance with regulatory standards 

Communication with regulatory authorities for submission and approval 

Training and audit inspection to confirm the manufacturing process is processing as per Good Manufacturing Practice (GMP)

Review and analysis of CMC (chemistry, manufacturing, control) data

How Medwisdom Lifescience Can Help You In Pharmaceutical Regulatory Affairs?

At Medwisdom Lifescience, we are specialized in dossier preparation for pharmaceutical, which is the most important thing for product registration. We offers end to end regulatory solutions with compliance at cost effective rates. We provides regulatory affairs services compliance with specific country regulatory authority. Some of our expertise for pharmaceuticals regulatory affairs includes:

Dossier compilation with compliance 

CMC documents preparation for product registration 

Regulatory submission and timely approvals 

Product lifecycle management 

Global market consultancy services for regulatory affairs 

More details on website: https://medwisdom.in/

FAQs 

What Is CTD Dossier and Why It Is Important?

Common technical document (CTD) is a standardized format for regulatory submissions to simplify the process of product registration or approval. It is important for presentation of product data across the country where we wants our product to get registration.

What Is The Timeline For Drug Product Approval?

The timeline for drug product approval basically depends upon the regulatory authority and the country where you wants your product to market.