The Government of India, under the aegis of Ministry of Health and Family Welfare has notified the Medical Devices Rules, 2017, which is scheduled to come into force on January 1, 2018. These rules aims to provide high- quality life-saving medical technology at affordable prices and also formulates new norms for the medical devices sector to attract investments. The new rules have been framed in conformity with Global Harmonization Task Force and confirm to best international practices. A few cardinal features of the Rules are as follows -
Classification based on associated risks
Under these Rules, medical devices have been classified as per GHTF practices into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the Rules. The intent behind the regulation is – ‘higher the risk, higher the level of regulation’. The medical devices could range from simple devices such as thermometers and disposable gloves to X-Ray, CT, MRI machines and implantable devices such as stents and artificial joints.
Self-Compliance by manufacturers
These Rules have involved a concept of self-compliance by manufacturers and, accordingly, the manufacturing licenses for Class A medical devices will be granted without prior audit of manufacturing site. In this case, the manufacturers will be required to do self-certification of compliance with the requirements and based on such certification, the license will be issued. However, post approval audit of manufacturing site will be carried out by the Notified Bodies to check conformance with Quality Management System.
Standards for medical devices
The medical devices shall confirm to the standards laid down under Bureau of Indian Standards. However, if no standards are specified then they are required to confirm to the standard laid down by the International Organization for Standardization (ISO) or the International Electro Technical Commission. Also these rules have been framed in conformity with Global Harmonization Task Force (GHTF) framework.
Licensing for manufacture and import
These rules provide for separate licenses to be obtained for the manufacture and import of medical devices and also impose conditions to be fulfilled for obtaining these licenses. For the first time there will be no requirement of periodic renewal of licenses. Accordingly, manufacturing and import licenses will remain valid till these are suspended or cancelled or surrendered. In order to reduce paper work and promote speedy disposal of application, the entire process starting from submission of application to grant of permission/license will be done online.
For all manufacturing sites, Quality Management System will need to be aligned with ISO 13485. The Notified Bodies (accredited by the National Accreditation Board for Certification Bodies) would undertake verification and assessment of the quality management system of Class A and Class B category devices. Manufacture of Class C and Class D medical devices will be regulated by the Central Licensing Authority.
The new rules have relaxed the clinical trial norms. Clinical Investigation (clinical trials) of investigational medical devices (i.e. new devices) have also been made at par with international practices and, like clinical trials, these will be regulated by Central Drugs Standard Control Organization. The objective to conduct clinical investigation is to ensure patient safety and welfare and discovery of new medical devices. These rules provide for the compensation payable to the subjects of a clinical investigation.
The initiative taken by the Legislature in bringing out the Medical Devices Rules, 2017 will boost governments ‘Make in India’ campaign by providing conductive environment for domestic manufacturers and promoting economic growth, long term investments and entrepreneurship. At present only 15 categories of Medical Devises are present and they are not fully equipped to meet the requirements of medical devices sector. It is expected that these rules will facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety.