There is no dispute about why the med-tech industry is highly regulated. No matter how robust the sterilization or disinfection process, if the packaging and seal closures of a medical pouch are compromised, there is a significant risk of product contamination during shipping and storage that could pose a danger to the end-user. Moreover, we all know that “end-user” ultimately means you, me or someone we love.
Our industry willingly works to comply with the standards, their updates and the agencies that hold power to grant, decline or withdraw approvals. Once in the marketplace, the work continues. Achieving and sustaining regulatory and compliance approval has become increasingly complex, for several reasons.
First, the rise of the med-tech market as a global enterprise has shot up at a dizzying pace.
Second, the capabilities and ramifications of technology in medical devices have also exploded. These advancements have brought a sea of change to the journey of a medical device from concept to end-use.
Third, the fully implemented and enforceable EU MDR begins in May 2020. Any MDM planning to market anywhere in the EU will feel the full impact of the sweeping new regulations. One clear takeaway is that there is tremendous opportunity for innovation and growth. Another is that industry innovators should expect – and plan for – conditions that will keep all of us on our toes for the foreseeable future.
Considering marketing in a new country? Wondering how the MDR may impact your planning for that market? Here is a list of some of the agencies who may play a role:
FDA Food and Drug Administration and Center for Devices and Radiological Health – FDA regulates the sale of and monitors the safety of all regulated medical products.1 The CDRH is a lesser-known branch of the FDA, tasked with “protecting and promoting the public health.” Their work with medical devices is described as, ”advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the US.” With the US medical device market representing a 40% market share and $156Bn in 2018, US regulators remain steadfast in the mission they carry out, helping all markets promote patient safety and accessibility to life-changing medical products. FDA.gov.
Health Canada – The Canadian counterpart to, and a close partner with the US FDA, most medical device creators are familiar with stringent Canadian requirements of its efficacy and safety reviews. With an approximate $7 Bn (USD) annual medical device market, the growth opportunity is strong.
For MDMs entering the Canadian market, understanding the converging regulatory forces may be helpful. Health Canada oversees the process and approves medical devices. Legislative direction and standards for med tech approvals are outlined in the Therapeutic Products Directorate (TPD). The TPD applies regulations detailed in the 1920 Parliamentary Canadian Food and Drugs Act. The Act was most recently revised in 1985. In 2018, the government introduced a supplementary medical device Action Plan. This mandate fast-tracked the implementation of new, stronger medical device regulations for medical devices marketed in Canada, with the plan fully implemented by December 2019.
Dekra – Designated in August 2019 as a Notified Body, Dekra was the third firm to become formally authorized by the EU to oversee and direct medical device conformity to MDR standards. Except for Class 1 devices, all new devices require certification by an NB. The transformative document becomes fully enforceable for all products marketed in the EU in May 2020. Dekra is also a Medical Device Single Audit Program (MDSPA) auditor and a global certification resource for medical devices.
TUV (SUD) – The original term “Technischer Überwachungsverein” may be obsolete, but its short form “TUV” is well known. The English adaptation for TUV is “Technical Inspection Association.” While not a governmental agency, TUV operates as a regulator through Germany as an EU Member State.
TUV SUD recently became the second officially designated EU Notified Body (BSI was the first) for certification and inspections as the MDR reaches its fully operational state in May 2020. Their 30+ locations in most major markets and NB status make the TUV SUD a likely new partner for many MDMs in the coming shift of EU MDR.
Central Drugs Standard Control Organisation (CDSCO) oversees the approval and distribution of pharma and medical device products in India. The regulatory practices are stated to be similar to the European Medicines Agency, the EU, and other countries. The CDSCO also interacts with the European Union as a trade partner. The medical device market in India shows an ongoing upward trend. Business Wire reported a $4.8 Mn USD value for the Indian medical device market in 2017. As a tech leader with the world’s fastest-growing economy and a keen eye on med-tech industries, India is a country to watch for medical device opportunities.
Medicines and Healthcare Regulatory Agency (MHRA) – With the unknown trajectory of the United Kingdom’s Brexit scenario, who is in charge of British med-tech makers when it comes to compliance? Officially, deal or no deal, Member State or sovereign, medical devices marketed in the UK must satisfy the Medicines and Healthcare (Products) Regulatory Agency (the UK’s governmental iteration of the US FDA). With a medical device industry that reached nearly $11Bn USD in 2018, the UK market is likely to remain a substantial opportunity for US MDMs, with the overall alignment of regulatory expectations and shared commitment to global harmonization efforts.
National Medical Products Administration (NMPA) (Until 2018, named the China Food and Drug Administration) – The People’s Republic of China market for medical device and IVD marketing is involved. The NMPA name was one of multiple 2018 regulatory shifts ushered in by the Ministry of Justice. The NMPA classifies devices according to its Medical Device Classification Catalog from 2017. A China-based coordinator must be assigned to manage foreign device registration. The process and data required for approval varies greatly by device class. Among the updated regulations are simplified clinical evidence requirements and more punitive penalties for post-market noncompliance.
In spite of potential trade issues between the US and China, medical device imports are one of China’s fastest-growing market sectors.
Becoming familiar with the operations of regulators across borders and cultures sets the stage to broaden your market, align your programs and anticipate what’s ahead for every medical device maker and supporting industry. With a new generation of global integration and the upcoming EU MDR, expert compliance partners and communication have never been more critical to success.