IMA Approval

Overview of the 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. CorpBiz expects a shift in consumer habits and choices impacted by the coronavirus pandemic with a greater focus on health, sanitation and protection, according to a top company official. 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. Besides, the CorpBiz sees a more significant role by online sales channels, which it believes will emerge strongly.

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. 

With the rising possibilities in India comes increasing ordinances that companies must face and overcome. With the assistance of a highly endured third-party regulatory compliance consultant such as CorpBiz, the registration process is much less complicated. We can help you develop and submit the required reports and materials to the relevant regulatory agencies in India.

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 sciencesin 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 authorised 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 Licence
• 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

 Step-By-Step With CorpBiz  Prepare

• Review Criteria

Evaluate relevant criteria for the product you want to certify.

Specific criteria are common to all products, while others are product-specific. Make sure to be intimate with the elements and verification processes relevant to your product.

• Join With Us

Book an introductory meeting with CorpBiz Development, online or in-person

If you're implementing for the first time, a reception with our certification team will help import you to the certification process. Communicate our certification team to set it up.

• Sign Agreement

Before confirming your products, sign an understanding with IMA Development.

If you're a first-time consumer, you need to sign an affidavit before applying for certification. Reach us for details.

• Contact A Verifier

Reach to one of the verifiers accredited by CorpBiz Developer. They carry out merchandise testing and verify compliance with the criteria.

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 paper works to the verifier for independent inspection.

Fill out the environmental paper works, 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 paper works is needed.

• Social Documentation

Send social responsibility paper works to the verifier for Independent Inspection.

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

• Receive Reports

Once the reports and the paper works 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

Option 1

Once you have received the approvals, reports and the Verification of Conformity (VOC), it's tit 'to apply for IMA Certified. Send all Documents to us along with a completed application form, or upload it to IMA Certified Portal.

Option 2

Instead of applying yourself, you can let as authorized verification organization use on your behalf. They are familiar with the application process, will help you with the functional details and also upload the necessary erudition to IMA Certified Portal.

Your product is certified!

• ADVERTISE YOUR CERTIFIED PRODUCTS- Well-wishing!

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

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. You will get a certificate as a PDF file, and all approved products will be listed in our Product Acquirer. We stimulate you to use the IMA Certified brand in your information related to the recommended products. For guidance, check our brand book. 

Why Choose Corpbiz?

CorpBiz Medical products Service specialists have first-hand experience about current and proposed regulations affecting medical device/products access to the Indian market and manage effective communications with governmental regulators and agents of international manufacturers. Also, CorpBiz Medical products Service’s expertise in global professional and regulatory issues appropriate to the medical product can ease the medical products endorsement process and India and other nations. 

Our Assistance at a Glance

• Pharmaceutical products security testing and certification- CorpBiz Medical products Setting is an IMA Notified Body for the medicinal product and known by other regulatory agencies everywhere the world for its extensive expertise with a broad range of medical product.

• Risk administrators Efficient- CORPBIZ experts have vast exposure in every phase of risk control methods for medical product manufacturers following ISO 14971 and conduct thousands of in-depth peril management reviews each year. 

• Biocompatibility Evaluations - CORPBIZ sister Consultants laboratories conduct biocompatibility tests in assent.

• Additional testing and certification services- CORPBIZ Medical products Service can also provide acquiescence testing for the medical product following other applicable regulations and standards, including IEC 60601-1 and electromagnetic compatibility (EMC) etc. 

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.