The current Indian market is conducive for setting up a medical device manufacturing business.  Selecting the correct location for setting up your medical device manufacturing facility is vital for the success of your business. This blog provides some tips for medical device manufacturing site selection. We have also highlighted some common requirements for setting up a medical device factory.

Current Indian medical device market

In the last decade, the medical devices industry in India has been growing at double digit rates. This industry has been evolving continuously. Factors, such as increase in life expectancy and public awareness, have contributed to an increasing demand for high-quality devices. Presently, India is among the top 20 global medical device markets and the 4^th largest in Asia. However, the growth of the Indian medical device industry is being impeded by certain factors.

In India, the medical devices industry is still relatively small and considerably relies on imports. Availability, affordability, and quality of medical devices affect the growth of the medical devices industry in India.

To promote the medical device manufacturing industry in India, the government is setting up 4 medical device parks. Development of infrastructure and testing labs in these parks will support medical device manufacturing in India. Government initiatives, like Make in India Scheme, is aimed at reducing the import reliance of the medical device industry.

To cater to the Indian needs of affordable and high-quality medical devices, setting up medical device manufacturing business in India is necessary. The Indian government is aimed at making India a global hub for medical device manufacturing. Hence, now is a good time to start a medical device manufacturing business in India. To start this business, you need to select the appropriate land for setting up a medical device manufacturing facility. Choosing the correct land for medical device manufacturing site will go a long way in the success of your business.

Common requirements for setting up a medical device manufacturing site

• Raw materials: The necessary raw materials for manufacturing medical devices have to be procured from a trusted supplier. The quality of the manufactured medical device will depend on the quality of the raw materials used. The procured raw materials have to be tested for compliance with required quality standards. An inventory of all raw materials to be used at any stage of the medical device manufacturing process has to be maintained. It is important to keep a proper record of the raw materials and assign a reference number. Certain part of the medical device manufacturing factory has to be dedicated for the proper storage of the raw materials.
• Machinery and necessary equipment: Depending on medical device to be manufactured, various manufacturing equipment and machinery will be required. Equipment commonly required are moulding machine, hand pressing machine, weighing devices, sealing machine, electro polishing machine, compressor, etc. HEPA filter, packing machine, inspection unit, air-conditioning unit are some of the other requirements for the medical device manufacturing facility. Machinery for assembling the components of a medical device will also be required. A dedicated area will be required for assembling the medical devices.
• Sterilization equipment and unit: Different medical devices require different sterilization techniques. Depending on the medical device to be manufactured a sterilization unit has to be set up. Ethelyne oxide sterilisation, steam sterilisation, dry heat sterilisation are some of the techniques required for sterilisation. The different sterilisation units have different sterilisation machinery requirements. Accordingly, a sterilization unit has to be set up in the medical device manufacturing site.
• Testing unit: Manufacturing high quality medical devices is of utmost importance. Quality control system and medical device testing unit will be required to evaluate the quality and efficacy of the device. A robust quality control system goes a long way in delivering high quality medical devices.
• Storage area: A medical device manufacturing factory will require a safe and secured storage area. Different medical devices have different storage requirements. Sterilized products will have to be stored in a sterile manner. Hence, while constructing the medical device manufacturing site, a designated storage area for the finished product has to be built.
• General requirements:  Selecting the appropriate land for medical device manufacturing facility is critical for the success of your business. The factory premise has to be clean well-ventilated and should be able to restrict the entry of rodents and insects. Proper sanitary conditions and water proofing of the facility have to be maintained. Temperature and humidity control of the manufacturing facility will be required. This will facilitate manufacturing medical devices in a hygienic environment. Additionally, a proper waste disposal system is a fundamental requirement for any factor. Furthermore, requirements, such as clean uniform and safety equipment, for the medical device technical personnels have to be provided. Moreover, proper water supply and first aid for factory workers will be required.
• CDSCO registration and licensing: CDSCO is the apex regulatory body for all medical devices manufactured and sold in India. To manufacture medical devices in India, you have to comply with the CDSCO regulatory guidelines. Different medical devices have different regulatory requirements. These CDSCO regulatory guidelines and requirements are difficult to understand and comprehend. We at Pharmadocx Consultants will be happy to be your CDSCO regulatory support. By availing our medical device regulatory service, you can obtain your CDSCO manufacturing license in a hassle-free manner.

For designing the layout and setting up the manufacturing facility, feel free to contact us. By availing our factory designing and layout service, you can rest assure that your factory will be CDSCO regulatory compliant. 

6 Tips for medical device manufacturing site selection

We cannot emphasize enough the importance of choosing the appropriate land for medical device manufacturing site setup. Availability of skilled medical device technical personnels, easy transportation access, and labour cost at the land selected for factory setup will influence the business. Thus, site location plays a vital role in the success of a medical device manufacturing business.

Factors to consider while selecting the appropriate land for setting up a medical device manufacturing facility:

1. The cost of doing business at the selected site: Manufacturing facility lease rates or the cost of constructing a manufacturing facility at the location of the selected land need to be evaluated. Utility costs, electricity costs, and labour costs need to be considered while choosing the land for the factory.
2. Environmental regulations: Factory sites and lands are subjected to environmental regulations. You need to be aware of the applicable environmental regulations and laws at the factory site.
3. Regulatory requirements: The regulatory requirements may vary from one area to another. Proper knowledge of the applicable regulations is required. You need to understand whether the regulations are favourable for setting up a medical device factory.
4. Availability of skilled medical device technical personnels: Medical device technical personnels are the ones who will be involved in the day to day running of the medical device factory. Hence, availability of skilled medical device technical personnels at the selected medical device manufacturing site is crucial.
5. Easy access to transportation: The accessibility of the selected land to the transportation network is a vital factor to consider. Close proximity to interstate highways, railways, and airports will help to swiftly transport goods. Swift and efficient movement of raw materials and finished products will help reduce medical device production and product delivery times.
6. Attitude of the community at the selected land: Many states are eager to attract businesses and will offer necessary assistance to set up a factory. Non-supportive community will only interfere with your business and cause hindrance.

You may refer to the above tips when selecting your medical device manufacturing site. Whether you need help with designing your factory or CDSCO regulations, we will be glad to be at your service.  Simply call/Whatsapp on 9996859227 or email at [email protected] and we will revert.