Posted by Personal Protective Equipment (PPE) has become an essential part of our lives. The pandemic showed its significance for safety in healthcare and daily use. In India, the Central Drugs Standard Control Organization (CDSCO) plays a key role in regulating PPE medical devices so they meet the necessary safety and quality standards. In this blog, we’ll explain the regulatory framework for CDSCO Personal Protective Equipment medical devices, with a focus on securing approval for importing, manufacturing, and further marketing them.
CDSCO’s Role in PPE Regulation
The CDSCO is the national regulatory body for medical devices in India. It functions under the Ministry of Health and Family Welfare. The Medical Devices Rules 2017, governs medical devices, including PPEs.
The value of the PPE market is set to reach USD 4,838.7 million by 2033 in India. This surge in the demand for these products requires compliance with Indian regulations for manufacturers and importers. Otherwise, securing a CDSCO license for PPE is challenging.
Besides issuing licenses for manufacturers and importers, this authority passes a loan license to manufacture PPE devices using another manufacturer’s approved premises. It also sanctions No Objection Certificates (NOCs) and special approvals for regulatory purposes like clinical investigations and special imports.
CDSCO Classification of Personal Protective Equipment
You may think that all PPEs fall under similar regulations, but CDSCO classifies them based on certain parameters. These include their use, functionality, and the level of risk associated with them. You can find the list of medical devices for PPE on the official website of CDSCO. Knowing the classification of your PPE is essential. It impacts the entire approval process for the CDSCO Personal Protective Equipment medical devices license. It also influences the registration fees, testing requirements, and timelines for getting the approval. Broadly, the PPE medical devices fall into Class A and B.
- Class A PPE are low-risk medical devices, such as Face Shield, Radiation Protection apron etc.
- Class B PPE are devices with a higher risk to the patient, such as a Sterile Surgical Gown, Surgical Gloves etc.
Here’s the official classification through which you can find out the risk class of your PPE device.
|
S. No |
Medical Device Name |
Risk Class |
| 1 | Garment, Protective for Incontinence | A |
| 2 | Biosanitizer for Medical devices | B |
| 3 | Face shield | A |
| 4 | Latex surgical glove | B |
| 5 | Non-latex surgical glove | B |
| 6 | Radiation protection gloves | A |
| 7 | Partial hand radiation protector | A |
| 8 | Radiation protection apron | A |
| 9 | Radiation protection mitten | A |
| 10 | Radiation protection goggles | A |
| 11 | Radiation face protector | A |
| 12 | Operator radiation protection spectacles | A |
| 13 | Gonadal radiation protector | A |
| 14 | Radiation protection blanket | A |
| 15 | Radiation protection collar | A |
| 16 | Radiation protection cap | A |
| 17 | Mobile radiation protection barrier | A |
| 18 | Non-latex medical examination glove | A |
| 19 | Latex medical examination glove | A |
| 20 | chemotherapy spill clean-up kit | A |
| 21 | Medical/Cadaver Body Bags | A |
| 22 | Surgical gown (Sterile) | B |
| 23 | Surgical gown (Non-Sterile) | A |
| 24 | Isolation Gown ( Sterile) | B |
| 25 | Isolation Gown (Non-Sterile) | A |
| 26 | Patient Gown | A |
| 27 | Professional Examination Gown | A |
| 28 | Personal Protective Equipment | B |
| 29 | Surgical Helmet | A |
| 30 | Surgical Cap | A |
| 31 | Operating Room Shoes Cover | A |
| 32 | Surgical Drape & Drape Accessories | B |
CDSCO License for Personal Protective Equipment in India – Process for Manufacturers
For manufacturers in India, CDSCO requires them to follow strict regulations. This makes sure that the products are safe and rich in quality. This process comprises obtaining the necessary licenses before beginning production. The key steps and requirements are as follows:
1. Pre-Market Approval
Before launching any PPE product in the Indian market, manufacturers must receive product approval from CDSCO. This is stated under the Medical Device Rules (MDR) 2017. The MDR classifies PPE medical devices based on their risk level. PPE such as Shield, Gloves, Gowns, and Biosanitizer fall under various risk classes, as mentioned above. The approval depends on the classification. To get the license, you must submit:
- Test license
- Plant Master File including Detailed layout (drawing) of your facility
- Sale or rent deed of the premises
- Device Master File
- Certificate of Analysis of 3 PPE devices
Only after this approval, you can legally produce the device.
2. Quality Management Systems (QMS)
The next key requirement is QMS. Manufacturers need to enforce stringent quality management systems aligned with ISO 13485. Compliance with ISO 13485 allows the manufacture of PPE products that meet the regulatory and quality benchmarks. This involves:
- Proper design controls
- Production monitoring
- Risk management
- Traceability protocols
3. Clinical Testing
For higher-risk PPE products, additional clinical testing or performance validation is significant. This validation is important due to the devices being used in healthcare settings with high infection risk. These include hospitals or isolation wards. Clinical testing confirms that your PPE is effective against pathogens. Such a product functions dependably under real-world conditions. CDSCO mandates that your reports for clinical testing be from accredited laboratories.
4. Product Labelling
All PPE devices must have accurate labelling. It should be compliant with standards set under the Medical Devices Rules 2017. Proper labelling helps in the identification of genuine products and understanding how to use them safely. Non-compliance with labelling norms can lead to delay in approval process.
Process to Obtain CDSCO Import License for PPE
Obtaining the necessary permissions makes sure that imported PPE products are safe and reliable. The key steps include:
1. Product and Site Registration
Importers must apply to CDSCO for import registration for each PPE medical device they intend to bring into India. These needs submitting detailed documentation. It is proof that your product complies with recognised international standards. Some major certifications include the following:
- Free Sale Certificate from any one of these following countries like United States of America, United Kingdom, European Union, Japan, Canada and Australia
- CE marking (European Conformity)
- Other equivalent global certifications demonstrating safety and efficacy
The registration application must include
- Plant Master File
- Device Master File
- Technical specifications
- Clinical and laboratory test reports
- Quality certifications
2. Inspection and Testing at Point of Entry
When PPE ships into India, CDSCO officials thoroughly verify certificates and documentation for it. They cross-check the registration approval, certifications, and reports. Some samples may need additional testing at CDSCO-recognised laboratories.
Any discrepancies or non-compliance detected during this stage delay in clearance, and in extreme cases, lead to unwarranted demurrage at port offices.
Consequences of Non-compliance with CDSCO Regulations
Non-compliance with CDSCO PPE license regulations has grave consequences for manufacturers and importers.
- It can lead to license suspension or cancellation, which can disrupt your ability to do business in India.
- Non-compliant products may be recalled and damage a brand’s reputation.
- The manufacturing license or import permission can be revoked if your PPE fails to meet the required standards.
How Dueran Consultant Helps You?
Dueran Consultant is a leading medical device consulting company in India. We have a huge team of regulatory professionals who provide effective guidance to businesses desiring to import their medical devices in India. We also help you obtain the necessary documents to quicken the process of approval. If you are currently struggling with a process, we identify gaps and fix them with best practices. Our expert assistance ensures you to thrive in your manufacturing or import business in India. We are always available for a quick chat or consultation with you.
Frequently Asked Questions (FAQ’s)
1. What are the types of personal protective equipment in healthcare sector?
Medical PPE includes surgical and non-surgical masks, gloves, gowns, face shields, and more. These address the safety needs of professionals and patients in a medical setting.
2. Who issues PPE guidelines?
In India, the Ministry of Health & Family Welfare and CDSCO issue guidelines for the selection and use of PPE in different medical environments.
3. How many PPE categories are there?
PPE is generally classified into categories such as body protection (gowns, coveralls), respiratory protection (masks, respirators), hand protection (gloves), eye/face protection (goggles, face shields), and foot/head protection (shoe and head covers).
4. What is a PPE kit?
A PPE kit is a pre-packed set. It has vital personal protective equipment for healthcare or emergency use. It has items like masks, gloves, gowns, face shields, and eye shields.
5. Who certifies PPE?
In India, the Central Drugs Standard Control Organization (CDSCO) certify PPE.
