Indian Medical Association and Medical Products

The coronavirus is making a notable impact on our daily lives in every respect. This involves a growing influence on the global economy and the day-to-day business actions of pharmaceutical and medical device companies. Herewith, we summarize the evolving situation and its implications on the progress of life sciences companies. Aiming to address, the changing requirements of consumers, the first plans to precede the new medical product in the sanitizer category, are extending its offering. 

India represents a compelling market opportunity for global medical products manufacturers, with the preponderance of medicinal product sold in India introduced from other countries. Substantial growth for the Indian medical product industry is expected to be inspired by the current low per-person spending rate for a medicinal product. 

Indian Medical Association

The Indian Medical Association is the only delegate, national voluntary organization of 'Doctors of Modern Scientific System of Medicine', which looks after the attention of doctors as well as the wellbeing of the society at large.

It resulted in the establishment of 'Indian Medical Association' and entered an agreement with the 'British Medical Association' that they will have no office in India, and got co-operatively affiliated, which relationship continues till today. As an industry, it has been and remains to play an essential role in its discussions. To develop and advance medical, allied sciences in all their different departments and to promote the development of public health and medical education in India.

Advertisement Advantages on Approvals

• Medical products approvals help your brand be able to stand out.
  
• It may open up new businesses for your house.
  
• A reliable medical products endorsement can build brand trustworthiness.
  
• It makes a brand trigger for consumers.
  
• Advertisements give your brand personality.
  
• It speeds up the time expected to establish a market track.
  
• It creates a higher recognition rate for future customers.
  

Standard Requirements Suitable for all Documents are:

• Records must be designed, prepared, reviewed and distributed with care
  
• Supplies must be certified, signed and dated by relevant, competent and authorized persons.
  
• Records must have unambiguous contents: title, nature and purpose should be clearly stated. 
  
• Records must be continuously reviewed and kept up-to-date. 
  
• Records must not be hand-written, although where files require the entry of data.
  

Prerequisites for Application Form

• Name of the applicant with address, telephone, fax, e-mail etc.
  
• Copy of Manufacturing License
  
• List of approved medical Product
  
• List of medical product for which the firm has valid Certification. 
  
• List of medical product applied for issuance of permits & their composition.   
  
• Site Master File
  

Concrete Phases

Device Specifications 

• Bill of Materials 
  
• Drawings and schematics 
  
• List of Ingredients Component Specifications
  
• Material Composition 
  
• Formulations 
  
• Assemblies 
  
• Software specifications
  

Medical Production and Process Specifications 

• Medical production environment specifications 
  
• Cleaning procedures 
  
• Equipment specifications 
  
• Calibration procedures
  
• Process flow charts 
  
• Set-up procedures 
  
• Medical production methods 
  
• Medical production procedures
  

Quality Assurance 

• Acceptance criteria 
  
• Testing and measurement equipment 
  
• Inspection/test procedures
  
• Inspection/test forms
  
• Instrument charts 
  
• Reporting forms 
  
• Process control charts
  

Packaging and Labelling 

• Packaging and labelling specifications 
  
• Package/Label drawings 
  
• Instructions for Use 
  
• Service manuals
  
• Packaging/labelling review and control 
  
• Packing procedures 
  
• Shipping procedures 
  
• Customer feedback forms
  

Installation, Maintenance, and Servicing 

• Installation procedures 
  
• Service procedures 
  
• Tools, testers and instruments – for installation and servicing 
  
• Forms for installation and servicing – including regulatory forms as necessary
  

Application Procedure on Regime

• Internal medical production control
  
• Intervention of a Notified Bod
  
• Testing type-examination
  
• Conformity to type
  
• Medical production quality assurance
  
• Medical products quality assurance
  
• Medical products verification
  
• Unit verification
  
• Full quality assurance.
  

All the application needs three verification steps: Product measurement, environmental information and compliance with socially accountable manufacturing criteria.

Test and Verify

• Product Examination
  

Forward a specimen of your product for testing.

Conduct a representative product sample to an acknowledged verification foundation (IMA for testing of its features, emissions and energy-saving function. *Separate test fees will performed. 

• Environmental Documentation
  

Conduct the environmental documentation to the verifier for independent inspection.

Fill out the environmental documentation, including a classification of the product and the environmental supervision system, use of hazardous substances and material resource performance and send to the verifier. Every criterion includes learning about which documentation is needed.

• Social Documentation
  

Send social responsibility documentation to the verifier for Independent Inspection.

Choose in the documentation for all social efficiency criteria and send to the verifier. Each model includes information about which documentation is required. Universal declarations are submitted annually and reviewed by an authorized verifier. 

• Receive Reports
  

Once the reports and the documentation received and verified, the verifier will send the permissions to you.

They will give the test reports, the 'environmental' and 'social' approvals and confirmation of conformity, where the verifier verifies that the product meets all the criteria in IMA Certified.

Apply for IMA Certification

Once you have received the approvals, reports and the Verification of Conformity (VOC), it’s time to apply for IMA Certified. Upload all documents along with a completed application form to IMA Certified Portal.

Terms & Governance

• YOU will get exclusive right and license to utilize this name in connection with the advertisement, promotion, and sale of their medical products. This contract will be an agreement for those rights and services with the following terms being in place. 
  
• IMA will provide rights for YOU to hold all exclusive rights and licenses needed during the term of specified after verification.
  
• Including the ability for the use of any nicknames, initials, autographs, photographs, or any other property, concerning the advertisement or sale of mentioned medical products.
  
• YOU agree to pay all royalties due from sales of such medical product as agreed between parties. Any fees owed will be due every year and shall be payable or renewable.
  
• Upon YOUR request, IMA will make appearances for a limited/unlimited of times every year for photography and promotional purposes.
  
• YOU Understands endorsers’ obligations and other requirements, therefore, will provide ten days written notice before any appearances.
  
• During the Term of this Agreement, YOU shall supply Endorser, any medical product the Endorser may reasonably request in connection with charitable events.
  
• IMA has not entered into any employment or non-compete agreements with YOU, therefore, is prohibited from the endorsing of any third parties.
  

FAQs

Q. What is the impact on sanitization after COVID-19?

It is rightly said by the authorities that the shift in consumer habits and choices, impacted by the coronavirus pandemic with a greater focus on health, sanitation and protection.

Q. Why is Indian Medical Association an authority Body of Certification?

To develop and advance medical, allied sciences in all their different departments and to promote the development of public health and medical education in India.

Q. What are the advantages of product approvals?

It helps to be able to stand out, open up new businesses, reliable medical products endorsement' brand trigger for consumers, brand personality, higher recognition rate, time expected to establish etc.

Q. What to do after approval?

The Product is now approved, and you have got the next step in social and environmental accountability.

Q. What would make a difference after certification from IMA?

Endorsing your products to IMA Certified helps you reduce environmental and social risk related to your medicinal products and their manufacture, and enables you to communicate about product sustainability and credibility.

For more information on this visit www.taxaj.com

Posted by Pooja

Team Taxaj