On March 1st, 2019, Grace Palma, CEO of China Med Device, is interviewed by BioWorld MedTech about the revised registration guidelines for medical devices.
By Elise Mak, Staff Writer
HONG KONG – This week, China reported a plan to revise the registration guidelines for medical devices to facilitate product registration for med-tech developers and better align regulation with international norms.
“The registration guidelines contain the basic technical requirements for medical devices and in vitro diagnostics (IVDs) manufacturers. Although not binding, they are highly recommended and similar to the [U.S.] FDA guidance,” Grace Fu, CEO of Boston-based regulatory advisory firm Chinamed Device LLC, told BioWorld MedTech.
As the plan is laid out, med-tech developers will need to meet the new guidelines to renew registration of product or when applying for new registrations.
“Even if their renewals, which are required by the regulators every five years, have no changes, they still have to prove that the originally approved products can meet the new requirements,” said Fu.
“As a result, your originally approved products will still need to go through local type testing to show that you are current with the new guidelines.”
Last year, Chinese regulators published 372 final and draft technical guidelines, including guidelines for non-clinical studies, clinical trials, design, manufacturing and registrations. Fu added that this is the first time Chinese regulators have made a plan that only concerns registration guidelines.
The move underlines China’s efforts to streamline registration processes for medical devices. The plan includes looking into documentation methods, such as guidelines on submitting supplementary information for priority review and guidelines on digital submission.
The plan also covers technical requirements for 86 medical devices, ranging from active devices, non-active devices to IVD devices.
The active devices included in the plan are endoscopy electrosurgical unit, endoscopy for gastrointestinal tract, X-ray computed tomography system, artificial intelligence (AI)- aided medical devices, noninvasive transcutaneous pacing, implantable and non-implantable magnetic resonance device, dental digital impression instrument, home-use pulse oximeter and so forth.
Meanwhile, the plan puts non-active devices such as bioresorbable polymer drug-eluting coronary stents, balloon dilatation catheters, knee replacements, dura mater patches, intraocular lenses, orthokeratology corneal reshaping lenses, metal intramedullary nails, firm embryo transfer catheters for assisted reproduction, fallopian tube catheters and facial prosthesis under its scope.
Added to the list are also IVD devices, such as hepatitis B virus E antigen and E antibody detection reagents, thalassemia gene detection reagents, dengue virus nucleic acid detection reagents, EB virus nucleic acid detection reagents, rheumatoid factor detection reagents and home-use IVD devices.
“Most of the guidelines that are to be revised according to the plan are published for the first time. For example, ‘AI-aided medical device’ is a new category,” said Fu.
“The Medical Device Classification Catalogue, which came into effect in August last year, includes AI diagnostics for the first time. This means the regulators are looking to classify medical devices first before coming up with registration guidelines,” she added.
Most notably, five 3D-printed devices also appear on the list in the plan. They are 3D-printed spine fusion cages, acetabular cups, spinal implants, bone implants and mandibles. The move follows the publication of a general version of the 3D Printed Medical Device Guideline in February 2018 by China’s Center for Medical Device Evaluation.
“The series of 3D-printed medical device guidelines will propel China to be the leader in innovation and market acceptance in orthopedic and dental applications,” she said.
Fu said for innovative medical devices, there is no predicate device to compare to. Patient volume is limited and there are no readily available referenced devices.
“As such, Chinese regulators are only asking for 10 to 20 pairs of observatory studies. They can be used in conjunction with history data to conduct the general analysis. A three-month follow up period is the minimum requirement to determine the observatory clinical benefits. It is relying on post market follow up evidence with such a short endpoint and small sample size,” she explained.
Fu said the detailed outline helps manufacturers generate clinical data for different clinical indications a lot faster and cheaper.
“With the orthopedic sector growing at some 20 percent annually, those guidelines can certainly put China in the forerunning position in orthopedic and dental 3D printed devices,” she added.
Last year, Chinese regulators announced a three-year plan to produce more than 300 industry standards for medical devices, IVDs and quality systems by the end of 2020.